Summary of PMA Originals & Supplements Approved
- Originals: 1
- Supplements: 81
Summary of PMA Originals Under Review
- Total Under Review: 50
- Total Active: 24
- Total On Hold: 26
Summary of PMA Supplements Under Review
- Total Under Review: 522
- Total Active: 424
- Total On Hold: 128
Summary of All PMA Submissions
- Received Originals: 4
- Supplements: 99
Summary of PMA Supplement PMA Approval/Denial Decision Times
- Number of Approvals: 81
- Number of Denials: 0
- Average Days Fr Receipt to Decision (Total Time): 200.4
- Days FDA Time: 132.2 Days
- Days MFR Time: 68.2 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P090029 7/24/14 |
PRESTIGE® LP Cervical Disc | Medtronic Sofamor Danek USA, Incorporated Memphis, TN 38132 |
Approval for the PRESTIGE® LP Cervical Disc. This device is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The PRESTIGE® LP Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the PRESTIGE® LP Cervical Disc. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N16837/S015 7/14/14 Special |
Artegraft Collagen Vascular Graft | Artegraft, Inc. North Brunswick, NJ 08902 |
Approval for a labeling change to modify the sizing convention from outer diameter to inner diameter of the graft. |
| P870024/S049 7/28/14 180-Day |
Paragon CRT®, Paragon CRT® 100, Paragon RG-4TM Rigid Gas Permeable Contact Lens for Overnight Corneal Refractive Therapy |
Paragon Vision Sciences, Inc. Mesa, AZ 85204 |
Approval for a labeling update to the Package Insert and Patient Information Booklet to include the results from a Section 522 Postmarket Surveillance Study (PAS). |
| P890003/S297 7/9/14 180-Day |
CareLink Encore Programmer, CareLink 2090 Programmer, CareLink Home Monitor, CareLink Express Monitor, CardioSight Reader, Device Data Management Application (DDMA) |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA). |
| P890003/S309 7/3/14 180-Day |
CareLink Monitor, CardioSight Reader, CareLink Express, Device Data Management Application (DDMA) |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Viva/Brava Quadripolar Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and is indicated for patients who require ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life- threatening ventricular arrhythmias, for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the classifications provided in the labeling. |
| P890055/S048 7/15/14 Special |
MedStream Programmable Infusion System | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval for an additional inspection step in the manufacturing process of the MedStream device to require a post-sterilization Fill Level Sensor (FLS) functional inspection. |
| P890055/S056 7/30/14 Real-Time |
MedStream Programmable Infusion Pump | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval to replace electrical gap welding or laser welding of the MedStream pump’s electrical components on the Printed Circuit Board (PCB) with a thermobrazing process, modify the extremity of the Flex FLS, Flex RF, and Battery Ribbon component to include apertures, and eliminate the current in-process micro pull test for each connection. |
| P890055/S057 7/11/14 180-Day |
Codman 3000 Constant-Flow Infusion Pump and MedStream Programmable Infusion | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval for a manufacturing site located at Sterigenics Belgium (Petit-Rechain) S.A. in Verviers, Belgium. |
| P910023/S336 7/24/14 Real-Time |
LATITUDE NXT Patient Management System, LATITUDE NXT Release 3.0 | St. Jude Medical Sunnyvale, CA 94085 |
Approval for cybersecurity updates to the Merlin@Home transmitters. |
| P910077/S143 7/16/14 Real-Time |
LATITUDE NXT Patient Management System | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the Wave Communicator Model 6280 sw version v1.52.00; Wave Communicator Model 6290 sw version v2.02.00; Wave Communicator Model 6498 sw version v1.52.00; LATITUDE NXT System Software Model 6460 v.3.00.01; and Communicator Accessory and Literature Kit Model 6250. |
| P950005/S050 7/2/14 135-Day |
Celsius, Celsius RMT, EZ Steer Non-Temp Sensing Ablation Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for applying a change in sterilization release method to the new line of catheters at the Santa Teresa, New Mexico facility. |
| P950015/S012 7/23/14 180-Day |
Heart Laser CO2 TMR System | Novadaq Tehnologies, Inc. Richmond, British Columbia Canada V6V 2A2 |
Approval for a manufacturing site located at Ethox, in Buffalo, New York. |
| P950037/S135 7/16/14 Real-Time |
REOCOR S/D External Pacermaker | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the replacement of the storage capacitor for the devices. |
| P960040/S316 7/16/14 Real-Time |
TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, and ORIGEN Family of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for Model 2868 Application Software version 3.04 and Firmware version A_v1.04 with Patch v4.01 and Firmware version B_v1.02 with Patch v3.01 for the devices. |
| P960058/S108 7/29/14 180-Day |
HiResolution Bionic Ear System: Concave Universal Head Piece | Advanced Bionics Valencia, CA 91355 |
Approval for the Concave Universal Head Piece, a redesigned version of the current Universal Head Piece. The Concave Universal Head Piece supports both behind the ear and body worn Sound Processors and is intended for increase of wearing comfort for the HiRes90K Advantage implant users. |
| P970003/S169 7/2/14 Real-Time |
DemiPulse Implantable Pulse Generator; Aspire HC Implantable Pulse Generator | Cyberonics, Inc. Houston, TX 77058 |
Approval for a change to the Printed Circuit Board Assembly manufacturing design requirement for voltage measurement accuracy and tolerance associated with its electrical testing. |
| P970004/S178 7/25/14 Special |
InterStim Therapy for Urinary Control | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changes to the labeling to add a warning regarding the risk of increased or uncontrolled bleeding and the use of anticoagulants prior to surgery for InterStim Therapy. |
| P980006/S022 7/11/14 180-Day |
Bausch & Lomb PureVision2 (balafilcon A) Visibility Tinted Contact Lenses, Bausch & Lomb PureVision2 Multi-Focal (balafilcon A) Visibility Tinted Contact Lenses, Bausch & Lomb PureVision2 Toric (balafilcon A) Visibility Tinted Contact Lenses Equate Monthly Single Vision (balafilcon A) Contact Lens, Equate Monthly Multi-Focal (balafilcon A) Contact Lens, Equate Monthly Toric (balafilcon A) Contact Lenses, and C-Vue ADDvantage Multifocal (balafilcon A) Visibility Tinted Contact Lenses |
Bausch & Lomb, Inc. Rochester, NY 14609 |
Approval for the addition of the following private label trade names: Equate Monthly Single Vision (balafilcon A) Contact Lens, Equate Monthly Multi-Focal (balafilcon A) Contact Lens, Equate Monthly Toric (balafilcon A) Contact Lenses, and C-Vue ADDvantage Multifocal (balafilcon A) Visibility Tinted Contact Lenses. The device, as modified, will be marketed under the trade name the Equate Monthly Single Vision (balafilcon A) Contact Lens and is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +8.00D to -20.00D when prescribed for up to 30 days of extended wear and from +20.00D to -20.00D for daily wear or extended wear up to 7 days. The Equate Monthly Single Vision (balafilcon A) Contact Lens is also indicated for therapeutic use. Use as a bandage contact lens for corneal protection and corneal pain relief during treatment of ocular pathologies as well as post-surgical conditions. Applications of the Equate Monthly. Single Vision (balafilcon A) Contact Lenses include but are not limited to conditions such as the following: 1) For corneal protection in conditions such as entropion, trichiasis, tarsal scars, recurrent corneal erosion and post surgical ptosis for corneal protection; 2) For corneal pain relief in conditions such as bullous keratopathy, epithelial erosion and abrasion, filamentary keratitis, post-keratoplasty; 3) For use as a bandage during the healing process of conditions such as chronic epithelial defects, corneal ulcer, neurotrophic keratitis, neuroparalytic keratitis, chemical bums, and post surgical epithelial defects; and, 4) For post-surgical conditions that include bandage use such as LASIK, PRK, PK, PTK, lamellar grafts, corneal flaps, and additional corneal surgical conditions. Equate Monthly Single Vision (balafilcon A) Contact Lenses for therapeutic use can also provide optical correction during healing if required. The device, as modified, will be marketed under the trade name The Equate Monthly Multi-Focal (balafilcon A) Contact Lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/ Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to -18.00D when prescribed for up to 30 days of Extended wear and from +20.00D to -20.00D for daily wear or extended wear up to 7 days with add powers ranging from +0.75D to +5.00D. The device, as modified, will be marketed under the trade name the Equate Monthly Toric (balafilcon A) For Astigmatism and is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to -9.00D when prescribed for up to 30 days of extended wear and from +20.00D to -20.00D for daily wear or extended wear up to 7 days. The device, as modified, will be marketed under the trade name the C-Vue ADDvantage Multifocal (balafilcon A) Visibility Tinted Contact Lenses and are indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or notaphakic persons with non-diseased eyes, exhibiting astigmatism of up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to – 18.00D when prescribed for up to 30 days of extended wear and from +20.00D to – 20.00D for daily wear or extended wear up to 7 days with add powers ranging from +0.75D to +5.00D. |
| P980016/S452 7/9/14 180-Day |
Maximo II DR, Maximo II VR, Virtuoso II DR, Virtuoso II VR, Secura DR, Secura VR Implantable Cardioverter Defibrillators |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA). |
| P980022/S154 7/10/14 Real-Time |
Paradigm REAL-Time Revel System | Medtronic Minimed Northridge, CA 91325 |
Approval to lower the purity specification limit for the Chromium layer on Enlite™ Glucose Sensor (MMT-7008) of the MiniMed 530G System and Sof™ Glucose Sensor (MMT-7002, MMT-7003) of the Paradigm REAL-Time Revel System. |
| P980023/S057 7/3/14 180-Day |
PROTEGO Family of ICD Leads | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the DF4 variants of the currently approved Ilesto/Iforia ICDs/CRT-Ds and LinoxSmart ICD leads. |
| P980025/S002 7/22/14 180-Day |
Logicon Caries Detector | GA Industries Rancho Palos Verdes, CA 90275 |
Approval for the addition of software module PreScan to Logicon Caries Detector. The device, as modified, will be marketed under the trade name Logicon Caries Detector and has revised indications for use: “The Logicon Caries Detector is a software device that is an aid in the diagnosis of caries that have penetrated into the dentin, on un-restored proximal surfaces of secondary dentition through the statistical analysis of digital intra-oral radiographic imagery. The device provides additional information for the clinician to use in his/her diagnosis of a tooth surface suspected of being carious. It is designed to work in conjunction with an existing Carestream Dental RVG digital x-ray radiographic system with Dental Imaging Software (DIS) for WINDOWS XP or higher.” |
| P980035/S358 7/9/14 180-Day |
Advisa DR, Advisa DR MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA). |
| P980040/S048 7/24/14 180-Day |
TECNIS OptiBlue 1-Piece intraocular lens | Abbott Medical Optics Inc. Santa Ana, CA 92705 |
Approval for a manufacturing site located at AMO Puerto Rico Manufacturing, Inc., in Anasco, Puerto Rico. |
| P990004/S024 7/2/14 180-Day |
SURGIFOAM Absorbable Gelatin Sponge, USP | Ethicon, Inc. Somerville, NJ 08876 |
Approval for a manufacturing (packaging) site located at Ferrosan Medical Devices, Koksowa, Poland. |
| P990071/S027 7/2/14 180-Day |
SmartAblate System | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for hardware modifications to the SmartAblate Irrigation Pump that update the hardware from version 1 to version 2. |
| P000058/S037 7/24/14 180-Day |
INFUSE® Bone Graft and INFUSE® Bone GraftLT-Cage Lumbar Tapered Fusion Device | Medtronic Spinal Memphis, TN 38132 |
Approval for a manufacturing site located at Wyeth Farma, S.A, in De Los Reyes, Spain. |
| P010012/S355 7/16/14 Real-Time |
COGNIS, INECEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, and ORIGEN family of CRT-Ds and Application Software | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for Model 2868 Application Software version 3.04 and Firmware version A_v1.04 with Patch v4.01 and Firmware version B_v1.02 with Patch v3.01 for the devices. |
| P010014/S048 7/7/14 Special |
Oxford® Partial Knee System | Biomet U.K. Ltd. Swindon, UK SN3 5HY |
Approval to update three contraindications in the Instructions for Use for the Oxford® Partial Knee System. |
| P010015/S227 7/9/14 180-Day |
Viva CRT-P, Consulta CRT-P, Syncra CRT-P |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA). |
| P010030/S051 7/14/14 Real-Time |
LifeVest® Wearable Defibrillator | ZOLL Lifecor Corporation Pittsburgh, PA 15238 |
Approval for a software change that will enable an analog clipping noise detector which will allow the system to better recognize when an input signal may be compromised due to saturation of analog amplifiers in the ECG signal processing circuitry. |
| P010031/S414 7/9/14 180-Day |
Concerto II CRT-D, Maximo II CRT-D, Consulta CRT-D, Consulta CRT-D DF4, Maximo II CRT-D DF4 |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Viva CRT-P Model C6TR01 Implantable Pacemaker with Cardiac Resynchronization; Programmer Software Application Model 9995 v8.3; and updates to the Medtronic CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and CareLink Express Model 2020B firmware, and to the Model 2491 Device Data Management Application (DDMA). |
| P010031/S442 7/3/14 180-Day |
Viva/Brava Quadripolar CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Viva/Brava Quadripolar Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and is indicated for patients who require ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life- threatening ventricular arrhythmias, for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the classifications provided in the labeling. |
| P010032/S075 7/2/14 180-Day |
Eon Mini and Protégé Implantable Neurostimulation Systems | St. Jude Medical Plano, Texas 75024 |
Approval for hardware and software modifications to the Eon Charging System Model 3726. |
| P010032/S078 7/7/14 Real-Time |
Eon Mini and Protégé Implantable Neurostimulation Systems | St. Jude Medical Implantable Electronic Systems Plano, TX 75024 |
Approval for updating firmware from version 3.0 to version 3.0.1 for Eon Mini (Model 3788) and Protégé (Model 2789) Implantable Pulse Generator that are used in Spinal Cord Stimulation therapy. |
| P010032/S079 7/14/14 Real-Time |
Protégé Implantable Neurostimulation Systems | St. Jude Medical Implantable Electronic Systems Plano, TX 75024 |
Approval for Rapid Programmer version 3.6 to support the programming of the Protégé neurostimulation devices (Model 3789 Protégé implantable pulse generator and Model 3852 patient programmer) as well as to make minor sustaining enhancements. |
| P010055/S009 7/30/14 180-Day |
ProstaLund CoreTherm System and ProstaLund CoreTherm Accessories | ProstaLund Operation AB Lund, Sweden SE-223 |
Approval for a manufacturing site located at Orifice Medical AB in Ystad, Sweden. |
| P010062/S008 7/28/14 180-Day |
Boston® Orthokeratology (Oprifocon A) Shaping Lens | Bausch & Lomb Rochester, NY 14609 |
Approval for a labeling update to the Package Insert and Patient Information Booklet to include the results from a Section 522 Postmarket Surveillance Study (PAS). |
| P010068/S039 7/2/14 135-Day |
Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for applying a change in sterilization release method to the new line of catheters at the Santa Teresa, New Mexico facility. |
| P020045/S054 7/17/14 Real-Time |
Freezor Cardiac CryoAblation System | Medtronic CryoCath LP Quebec, Canada H9R 5Z8 |
Approval for modifications to the Y-block distal diameter and the adhesive used in the Y-block to Shaft bond. |
| P030011/S024 7/2/14 180-Day |
SynCardia temporary Total Artificial Heart (TAH-t) System | SynCardia Systems, Inc. Tucson, AZ 85713 |
Approval for use of the SynHall valve in the SynCardia temporary Total Artificial Heart (TAH-t). |
| P030031/S044 7/1/14 180-Day |
Navistar RMT Thermocool Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a manufacturing site located at Biosense Webster, Inc., in Chihuahua, Mexico. |
| P030054/S268 7/24/14 Real-Time |
FAMILY OF MERLIN@HOME TRANSMITTERS | St. Jude Medical Sunnyvale, CA 94085 |
Approval for cybersecurity updates to the Merlin@Home transmitters. |
| P040002/S048 7/14/14 Real-Time |
AFX Bifurcated Stent Graft Delivery System | Endologix, Inc. Irvine, CA 92618 |
Approval for changes to the retraction stop on the inner core of the AFX Bifurcated Stent Graft Delivery System. |
| P040002/S049 7/30/14 Real-Time |
AFX Endovascular AAA System | Endologix, Inc. Irvine, CA 92618 |
Approval to modify the anchor bonding process of the front tip subassembly on the AFX Accessory Stent Graft Delivery System. |
| P040013/S018 7/11/14 Special |
GEM 21S (GROWTH-FACTOR ENHANCED MATRIX) | Luitpold Pharmaceuticals, Inc. Norristown, PA 19403 |
Approval for the revision of the GEM 21S package insert. |
| P040033/S027 7/30/14 Real-Time |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Cordova, TN 38016 |
Approval for an instrument to assist in femoral component sizing and positioning. |
| P040036/S032 7/1/14 180-Day |
Celsius RMT Thermocool Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a manufacturing site located at Biosense Webster, Inc., in Chihuahua, Mexico. |
| P040044/S056 7/30/14 180-Day |
Mynx Vascular Closure Device Product Family | Access Closure, Inc. Santa Clara, CA 95054 |
Approval to expand the indications for use to include closure of venous access sites in addition to the currently approved use for closure of arterial access sites. The device, as modified, will be marketed under the trade name MynxGrip Vascular Closure Device and is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. |
| P050010/S013 7/31/14 180-Day |
PRODISC L Total Disc Replacement | DePuy Synthes Spine Raynham, MA 02767 |
Approval for modified labeling to reflect findings of the post-approval study (PAS). |
| P050023/S076 7/3/14 180-Day |
Ilesto/Iforia DF4 ICDs/CRT-Ds | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the DF4 variants of the currently approved Ilesto/Iforia ICDs/CRT-Ds and LinoxSmart ICD leads. |
| P050031/S001 7/28/14 180-Day |
Paragon Z CRT® Lens | Paragon Vision Sciences, Inc. Mesa, AZ 85204 |
Approval for a labeling update to the Package Insert and Patient Information Booklet to include the results from a Section 522 Postmarket Surveillance Study (PAS). |
| P050033/S016 7/17/14 Real-Time |
Hydrelle | Anika Therapeutics Incorporated Bedford, MA 01730 |
Approval for changes to the stability protocol. |
| P050053/S015 7/24/14 180-Day |
INFUSE® Bone Graft and INFUSE® Bone GraftLT-Cage Lumbar Tapered Fusion Device | Medtronic Spinal Memphis, TN 38132 |
Approval for a manufacturing site located at Wyeth Farma, S.A, in De Los Reyes, Spain. |
| P060025/S013 7/30/14 180-Day |
Medtronic 3f Aortic Bioprosthesis | Medtronic Structural Heart Santa Ana, CA 92705 |
Approval for a manufacturing site located at Medtronic in Santa Ana, California. |
| P060037/S026 7/18/14 180-Day |
NexGen Complete Knee Solution, Legacy Knee – Posteriorly Stabilized (LPS), and LPS-Flex Mobile Bearing Knee | Zimmer, Inc. Warsaw, IN 46581 |
Approval for a manufacturing site located at Synergy Health located in Daniken, Switzerland. |
| P060038/S020 7/15/14 180-Day |
MitroFlow Aortic Pericardial Heart Valve (MAPHV™) | Sorin Group USA, Inc. Canada V5J 5M1 |
Approval of the post-approval study protocol. |
| P060040/S036 7/27/14 Real-Time |
Thoratec HeartMate II Left Ventricular Assist Device | Thoratec Corporation Pleasanton, CA 94588 |
Approval for software changes to the Backup Application of the Pocket Controller. |
| P070014/S044 7/18/14 180-Day |
Bard® LifeStent® Vascular Stent System | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Approval for a smaller stent diameter (5mm) with an identical design/cut pattern to the current LifeStent. |
| P070014/S045 7/11/14 180-Day |
LifeStent Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Approval of the post-approval study protocol. |
| P070027/S039 7/16/14 180-Day |
Talent Converter Stent Graft System & Talent Occluder System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval of the post-approval study protocol. |
| P080011/S030 7/8/14 135-Day |
CooperVision Comfilcon A Soft Extended-Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Approval for a new manufacturing line at the Puerto Rico facility. |
| P080025/S074 7/25/14 Special |
InterStim Therapy for Bowel Control | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changes to the labeling to add a warning regarding the risk of increased or uncontrolled bleeding and the use of anticoagulants prior to surgery for InterStim Therapy. |
| P100003/S004 7/16/14 180-Day |
SECURE®-C Artificial Cervical Disc | Globus Medical, Inc. Audobon, PA 19403 |
Approval of the post-approval study protocol. |
| P100009/S004 7/9/14 Real-Time |
MitraClip Clip Delivery System | Abbott Vascular Menlo Park, CA 94025 |
Approval for a new patient brochure. |
| P100021/S038 7/8/14 Special |
Endurant and Endurant II Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for introducing a lamp mandrel as a manufacturing tool for radiopaque contralateral gate marker inspection of Endurant and Endurant II Bifurcated Stent Grafts and a coil dispenser as a visual aid during the pre-kitting process of Endurant II Stent Grafts. |
| P100026/S017 7/9/14 Real-Time |
RNS® System | NeuroPace, Inc. Mountain View, CA 94043 |
Approval to use 20 micron thick separators in the QMR model 2570 battery. |
| P100027/S018 7/30/14 Real-Time |
INFORM HER2 Dual ISH DNA Probe Cocktail System | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for the extension of stability dating for the INFORM HER2 Dual ISH DNA Probe Cocktail system, which includes the following products: INFORM HER2 Dual ISH DNA Probe Cocktail, ultraView Red ISH DIG Detection Kit, ultraView SISH DNP Detection Kit. |
| P100030/S004 7/31/14 180-Day |
PreveLeak Surgical Sealant | Tenaxis Medical, Inc. Mountain View, CA 94043 |
Approval for a product trade name change from ArterX® Surgical Sealant to PreveLeak Surgical Sealant. The device, as modified, will be marketed under the trade name PreveLeak Surgical Sealant and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. |
| P100034/S008 7/24/14 180-Day |
NovoTTF-100A System | NovoCure, Ltd. Rye Beach, NH 03871 |
Approval for 1) design changes to the NovoTTF-100A connection cable to enhance its durability and 2) the addition of UNIXTAR Technology, Inc. as a second source supplier of the connection cables. |
| P100034/S009 7/25/14 Real-Time |
NovoTTF-l00A System | NovoCure, Ltd. Rye Beach, NH 03871 |
Approval to replace the current Tyvek pouch packaging material for the INE transducer arrays with an aluminum foil moisture barrier and to extend the shelf life for these transducer arrays from 6 to 9 months. |
| P100049/S010 7/22/14 Special |
Linx Reflux Management System | Torax Medical, Inc. Shoreview, MN 55126 |
Approval for labeling alterations including adverse event information about erosion of the LINX device, clarifications or contraindications regarding nickel, warnings regarding storage and use above 60 degrees C, additional potential risk of saliva/mucus build-up, and directions which add the removal of sutures after the clasp ends are fully engaged. |
| P110002/S005 7/15/14 180-Day |
Mobi-C Cervical Disc | LDR Spine USA, Inc. Austin, TX 78750 |
Approval of the post-approval study protocol. |
| P110009/S005 7/15/14 180-Day |
Mobi-C Cervical Disc | LDR Spine USA, Inc. Austin, TX 78750 |
Approval of the post-approval study protocol. |
| P110010/S083 7/18/14 Real-Time |
PROMUS Element™ Plus and Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the extension of the shelf life from 12 months to 18 months. |
| P110019/S063 7/3/14 135-Day |
XIENCE PRIME® Everolimus Eluting Coronary Stent System, XIENCE XPEDITION™ Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval to remove a stent inspection step. |
| P110019/S068 7/3/14 Real-Time |
XIENCE Xpedition™ Everoliums Eluting Coronary Stent System, XIENCE Xpedition™ LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition™ SV Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval to change the outer layer thickness specification for the inner member catheter component for the Xience Xpedition, Xience Xpedition SV, and Xience Xpedition LL Everolimus Eluting Coronary Stent Over the Wire (OTW) System. |
| P110033/S002 7/30/14 135-Day |
JUVÉDERM VOLUMA XC | Allergan Goleta, CA 93117 |
Approval for increased dryer capacity in JUVÉDERM VOLUMA XC manufacturing. |
| P120005/S019 7/11/14 Real-Time |
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Approval for a change to the transmitter that combines the components from two printed circuit board assemblies (PCBAs) into a single board transmitter (SBT) with one printed circuit board (PCB). |
| P120010/S021 7/10/14 Real-Time |
MiniMed 530G System | Medtronic Minimed Northridge, CA 91325 |
Approval to lower the purity specification limit for the Chromium layer on Enlite™ Glucose Sensor (MMT-7008) of the MiniMed 530G System and Sof™ Glucose Sensor (MMT-7002, MMT-7003) of the Paradigm REAL-Time Revel System. |
| P120020/S004 7/10/14 135-Day |
Supera Peripheral Stent System | Abbott Vascular Santa Clara, CA 95054 |
Approval for implementation of a semi-automated passivation process and a change to the passivation of stent couplings by an alternate vendor. |
| P130016/S002 7/1/14 Real-Time |
Nucleus® Hybrid™ Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for an MR indication at 1.5 tesla under specific scanning conditions with the magnet surgically removed prior to the MR scan, for the Hybrid L24 Implant System. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790007/S042 7/23/14 |
Hancock® Modified Orifice Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P830060/S080 7/30/14 |
VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P830061/S109 7/16/14 |
CAPSURE SENSE LEADS | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an equivalent sterilizer and aerator. |
| P840001/S270 7/2/14 |
RestoreSensor Rechareable Neurostimulator, RestoreSensor SureScan MRI Rechareable Neurostimulator |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Update to the process flow at the IC Supplier. |
| P840001/S271 7/3/14 |
ITREL, RESTORE, and SYNERGY SYSTEMS | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P840001/S272 7/17/14 |
ITREL,RESTORE, and SYNERGY SYSTEMS | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use alternate lasers for the laser bonding process. |
| P840001/S274 7/22/14 |
SCS Neurostimulators Implantable Restore Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use a new software test package. |
| P860004/S208 7/3/14 |
SYNCHROMED SYSTEM | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P860004/S209 7/24/14 |
SYNCHROMED SYSTEM | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing line move on the same Chaska, Minnesota campus, change in the inspection assembly process, removal of a cleaning step, and will discontinuing a manual fingerpull test. |
| P870078/S026 7/23/14 |
Hancock® Low Porosity Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P880086/S244 7/9/14 |
Accent SR RF, Accent DR RF | St. Jude Medical Sylmar, CA 91342 |
Modify the Device Post Sterilization Test (DPST) at ATE for the RF telemetry of the devices. |
| P900033/S037 7/3/14 |
INTEGRA Artificial Skin Dermal Regeneration Template | Integra Life Sciences Corporation Plainsboro, NJ 08536 |
Change in the Cleaning Validation to extend the Dirty hold time of Tanks TK-01 and TK-02 used in the Wet Processing Formulation. |
| P900056/S140 7/24/14 |
Rotablator Rotational Atherectomy System | Boston Scientific Corporation Maple Grove MN 55311 |
Change to the device component quality inspection process. |
| P910023/S340 7/10/14 |
Current+, Ellipse, Fortify, and Fortify Assura Families of ICD Devices | St. Jude Medical, Sylmar, CA 91342 |
Change in the temperature cycling range for hybrid assemblies. |
| P910023/S341 7/18/14 |
Fortify and Fortify Assura families of ICD devices | St. Jude Medical, Sylmar, CA 91342 |
Modification to the connector reinforcement process for hybrid assemblies. |
| P910073/S127 7/30/14 |
ENDOTAK LEAD SYSTEM | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P910077/S145 7/30/14 |
VENTAK PRX AND VENTAK MINI | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P920015/S132 7/10/14 |
Sprint Quattro Lead | Medtronic CRDM Mounds View, MN 55112 |
Modified testing frequency for the destructive pull test of the devices. |
| P920015/S134 7/28/14 |
Sprint Quattro Lead | Medtronic CRDM Mounds View, MN 55112 |
Addition of an alternate supplier for manufacture of the bifilar electrode coil for the devices. |
| P920048/S008 7/24/14 |
Rapid fFN Control Kit | Hologic, Inc. Sunnyvale, CA 94089 |
Change to add an intermediate solution in the manufacturing process of Positive Reference Calibrator, to modify the personnel in charge of in-process manufacturing testing and to increase the number of replicates in bulk solution concentration verification procedure for both Positive Reference Calibrator and Positive Control. The Positive Reference Calibrator and the Positive Control are components of the Rapid fFN Control kit for use with the TLiIQ Analyzer and fFN ELISA Test. |
| P930014/S073 7/16/14 |
AcrySof Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Addition of an alternate component supplier. |
| P930035/S027 7/30/14 |
VENTAK P2 PACEMAKER | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P930039/S110 7/8/14 |
CapSureFix Novus Lead | Medtronic, Inc. Mounds View MN, 55112 |
Add a helix linearity inspection at the final functional inspection and a helix linearity fixture to facilitate this linearity inspection. |
| P930039/S111 7/16/14 |
CAPSUREFIX NOVUS LEADS | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an equivalent sterilizer and aerator. |
| P950001/S027 7/30/14 |
SELUTE LEAD SYSTEM | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P950029/S091 7/16/14 |
Reply SR, Reply DR, Esprit SR, Esprit DR | Sorin CRM USA, Inc Arvada, CO 80004 |
Change to the in-process verifications for tantalum capacitors used in the devices. |
| P950029/S092 7/28/14 |
Reply SR, Reply DR, Esprit SR, Esprit DR | Sorin CRM USA, Inc Arvada, CO 80004 |
Change to a single pass process for screen printing and reflow soldering. |
| P950037/S136 7/11/14 |
Selox, TILDA, Solox Leads | Biotronik, Inc. Lake Oswego, OR 97035 |
Additional supplier for the conductor wires used in the manufacture of the leads. |
| P960004/S066 7/30/14 |
THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P960006/S043 7/30/14 |
SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEADS | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P960009/S196 7/3/14 |
ACTIVA, KINETRA, SOLETRA SYSTEMS | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P960040/S319 7/8/14 |
INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY, DYNAGEN, INOGEN, ORIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
Boston Scientific St. Paul, MN 55112 |
Add a functionally equivalent sterilization chamber; 2) add a third Abator to be used with the additional sterilizer; and 3) include sterilizer chamber enhancements required for the existing and additional sterilizer chambers. |
| P960040/S321 7/11/14 |
ORIGEN™ EL ICD; INOGEN™ EL ICD; DYNAGEN™ EL ICD; ORIGEN™ MINI ICD; INOGEN™ MINI ICD; DYNAGEN™ MINI ICD | Boston Scientific St. Paul, MN 55112 |
Add the laser etched scratches inspection criteria for the devices. |
| P960040/S322 7/8/14 |
PUNCTUA ICDs, TELIGEN ICDs, INCEPTA ICDs, ORIGEN ICDs, DYNAGEN ICDs |
Boston Scientific Corporation St. Paul, MN 55112 |
Add a replacement automated optical (AOI) inspection equipment for device identification and torque wrench verification. |
| P960040/S323 7/30/14 |
ICD ORIGEN, ICD INOGEN, ICD DYNAGEN, ICD PUNCTUA, ICD TELIGEN, ICD ENERGEN, ICD INCEPTA, ICD VITALITY |
Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P960040/S324 7/28/14 |
DYNAGEN™ EL ICD; INOGEN™ EL ICD; ORIGEN™ EL ICD; DYNAGEN™ MINI ICD; NOGEN™ MINI ICD; ORIGEN™ MINI ICD |
Boston Scientific Corporation St. Paul, MN 55112 |
Blister sealer process setting changes for the devices. |
| N970003/S165 7/8/14 |
INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO PACEMAKERS |
Boston Scientific St. Paul, MN 55112 |
Add a functionally equivalent sterilization chamber; 2) add a third Abator to be used with the additional sterilizer; and 3) include sterilizer chamber enhancements required for the existing and additional sterilizer chambers. |
| N970003/S166 7/30/14 |
PG INSIGNIA, PG ADVANTIO, PG INGENIO, PG VITALIO, PG FORMIO, PG ALTRUA |
Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P970003/S172 7/17/14 |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Automate a weld angle measurement process. |
| P970004/S176 7/2/14 |
SNS Urinary Verify Screening Trialing Systems (including Temporary Leads) |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Update to the process flow at the IC Supplier. |
| P970004/S177 7/3/14 |
SNS Urinary Extensions, SNS Urinary Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P970004/S179 7/30/14 |
Medtronic Verify External Neurostimulator (ENS) | Medtronic Neuromodulation Minneapolis, MN 55432 |
Acceptance to expand the manufacturing acceptance criterion. |
| P970031/S046 7/23/14 |
Freestyle® Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P980016/S486 7/11/14 |
Marquis DR ICD; Marquis VR ICD; Maximo DR ICD; Maximo VR ICD | Medtronic CRDM Mounds View, MN 55112 |
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries. |
| P980016/S487 7/17/14 |
Maximo II, Protecta, Protecta XT, Secura, Virtuoso II DR/VR ICDs | Medtronic CRDM Mounds View, MN 55112 |
Change in the epoxy dispense process for the devices. |
| P980016/S488 7/9/14 |
Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Maximo II ICD; Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso II DR/VR ICD |
Medtronic CRDM Mounds View, MN 55112 |
Reduction of Sonoscan detection method for the devices. |
| P980016/S490 7/30/14 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD |
Medtronic CRDM Mounds View, MN 55112 |
Additional equipment for the fill hole seal weld for the high voltage capacitor. |
| P980016/S491 7/22/14 |
Evera S DR/VR, Evera XT DR/VR, Maximo II, Protecta, Secura, Virtuoso DR/VR ICDs | Medtronic CRDM Mounds View, MN 55112 |
Modification on laser seam welder equipment at a final device manufacturing facility for the devices. |
| P980022/S157 7/18/14 |
Paradigm REAL-Time Revel System | Medtronic MiniMed Inc. Northridge, CA, 91325 |
Addition of a functional test during manufacture of the MySentry System (MMT-9100). The MySentry System (MMT-9100) consists of the MySentry Monitor (MMT-9101) and MySentry Outpost (MMT-9102) and is approved for use with the Paradigm REALTime Revel System. |
| P980022/S158 7/24/14 |
Paradigm® REAL-Time System and Paradigm® REAL-Time Revel System | Medtronic MiniMed Inc. Northridge, CA 91325 |
Change in the concentration of a raw material used during manufacture of the EnliteTM Glucose Sensor (MMT-7008) of the MiniMed 530G System and SofTM Glucose Sensor (MMT-7002, MMT-7003) of the Paradigm® REAL-Time System and Paradigm® REAL-Time Revel System. |
| P980023/S059 7/11/14 |
LINOX SMART SD, VIGILA, VOLTA | Biotronik, Inc. Lake Oswego, OR 97035 |
Additional supplier for the conductor wires used in the manufacture of the leads. |
| P980024/S013 7/16/14 |
PathVysion HER-2 DNA Probe Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Modify the validated test method MDP00644 “Fragmented DNA Agarose Gel Electrophoresis” of the manufacturing process of Vysis ALK Break Apart FISH Probe Kit, PathVysion HER-2 DNA Probe Kit and UroVysion Bladder Cancer Kit. |
| P980035/S380 7/11/14 |
Advisa DR IPG; Advisa DR MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries. |
| P980035/S381 7/16/14 |
Adapta, Versa, Sensia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an equivalent sterilizer and aerator. |
| P980035/S383 7/28/14 |
Adapta, Versa, Sensia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Update to seam weld parameters for the devices. |
| P980043/S046 7/11/14 |
Hancock® II Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new sewing machine for use with the cloth cover. |
| P980043/S047 7/23/14 |
Hancock® II Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P980049/S100 7/16/14 |
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR, Paradym RF VR, Paradym RF DR | Sorin CRM USA, Inc Arvada, CO 80004 |
Change to the in-process verifications for tantalum capacitors used in the devices. |
| P990034/S032 7/3/14 |
Drug Delivery Catheters, Drug Delivery Kits for Revisions | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P990064/S055 7/11/14 |
Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new sewing machine for use with the cloth cover. |
| P990064/S056 7/23/14 |
Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P000029/S078 7/31/14 |
Deflux Injectable Gel | Salix Pharmaceuticals, Inc. Raleigh, NC 27615 |
Qualify an alternate supplier of the ready-prepared solutions of NaOH and HCL used for the manufacturing of Deflux device. |
| P000046/S025 7/8/14 |
Staarvisc, Optivisc, NuVisc, Anikavisc Sodium Hyaluronate | Anika Therapeutics, Inc. Bedford, MA 01730 |
Change to the syringe residual solvent testing from a supplier’s contract laboratory to the supplier’s in-house facility for Anika’s ophthalmic devices. |
| P010012/S358 7/8/14 |
INCEPTA, ENERGEN, PUNCTUA, COGNIS, DYNAGEN, INOGEN, ORIGEN CRT-DEFIBRILLATORS | Boston Scientific St. Paul, MN 55112 |
Add a functionally equivalent sterilization chamber; 2) add a third Abator to be used with the additional sterilizer; and 3) include sterilizer chamber enhancements required for the existing and additional sterilizer chambers. |
| P010012/S360 7/11/14 |
DYNAGEN™ CRT-D; DYNAGEN™ X4 CRT-D; INOGEN™ CRT-D; INOGEN™ X4 CRT-D; ORIGEN™ CRT-D; ORIGEN™ X4 CRT-D | Boston Scientific St. Paul, MN 55112 |
Add the laser etched scratches inspection criteria for the devices. |
| P010012/S361 7/8/14 |
PUNCTUA CRT-Ds, ENERGEN CRT-Ds, INCEPTA CRT-Ds, ORIGEN CRT-Ds, INOGEN CRT-Ds, DYNAGEN CRT-Ds |
Boston Scientific Corporation St. Paul, MN 55112 |
Add a replacement automated optical (AOI) inspection equipment for device identification and torque wrench verification. |
| P010012/S362 7/9/14 |
EASYTRAK 2 IS-1 Coronary Venous Pace/Sense Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Extend the expiration term for plasma treatment and to add a process monitor. |
| P010012/S363 7/30/14 |
ACCESSORY, ORIGEN CRT-D, INOGEN CRT-D, DYNAGEN CRT-D, PUNCTUA CRT-D; ENERGEN CRT-D; INCEPTA CRT-D |
Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P010012/S364 7/28/14 |
DYNAGEN™ CRT-D DYNAGEN™ X4 CRT-DG; INOGEN™ CRT-D; INOGEN™ X4 CRT-D; ORIGEN™ CRT-D; ORIGEN™ X4 CRT-D | Boston Scientific Corporation St. Paul, MN 55112 |
Blister sealer process setting changes for the devices. |
| P010015/S241 7/11/14 |
Consulta CRT-P; Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries. |
| P010015/S243 7/24/14 |
Viva CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing changes to align the production of Viva CRT-P with existing market approved products. |
| P010031/S448 7/11/14 |
InSync III Marquis ICD; InSync Maximo ICD | Medtronic, Inc. Mounds View, MN 55112 |
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries. |
| P010031/S449 7/17/14 |
Concerto II, Maximo II, Protecta, Protecta XT CRT-Ds, Consulta ICDs | Medtronic CRDM Mounds View, MN 55112 |
Change in the epoxy dispense process for the devices. |
| P010031/S450 7/9/14 |
Brava CRT-D; Concerto II CRT-D; Consulta ICD; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva S CRT-D; Viva XT CRT-D |
Medtronic CRDM Mounds View, MN 55112 |
Reduction of Sonoscan detection method for the devices. |
| P010031/S452 7/30/14 |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic CRDM Mounds View, MN 55112 |
Additional equipment for the fill hole seal weld for the high voltage capacitor. |
| P010031/S453 7/24/14 |
Brava Quad, Viva Quad C, Viva Quad S, Viva Quad XT CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing changes to align the production of Viva and Brava models with existing market approved products. |
| P010031/S454 7/22/14 |
Brava, Brava Quad, Concerto II, Consulta, Maximo II, Protecta, Protecta XT, Viva Quad S/XT, Viva S/XT CRTDs | Medtronic CRDM Mounds View, MN 55112 |
Modification on laser seam welder equipment at a final device manufacturing facility for the devices. |
| P010032/S082 7/17/14 |
Eon Implantable Pulse Generator, Eon Mini Implantable Pulse Generator, Protégé Implantable Pulse Generator |
St. Jude Medical Neuromodulation Plano, Texas 75024 |
Upgrade the welding equipment used in a manufacturing process. |
| P010047/S035 7/2/14 |
Progel® Pleural Air Leak Sealant | Neomend, Inc. Irvine, CA 92618 |
Alternate Extended Applicator Spray Tip supplier. |
| P020004/S098 7/2/14 |
Excluder AAA Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center. |
| P020004/S099 7/2/14 |
EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>. |
| P020004/S100 7/2/14 |
Excluder AAA Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Updated hardware and software for FTIR spectrophotometer computers. |
| P020004/S101 7/2/14 |
Excluder® AAA Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer. |
| P020004/S102 7/21/14 |
Excluder® AAA Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
New tooling used in a molding process, replication of the molding process at an additional facility, and a new supplier of the molded component. |
| P020025/S062 7/14/14 |
BLAZER II XP CARDIAC ABLATION CATHETER-IntellaTip MiFi Filter Module, IntellaTip MiFi Reference Cable | Boston Scientific Corporation San Jose, CA 95134 |
Update to the current Manufacturing Execution System (MES). |
| P020025/S063 7/18/14 |
IntellaTip MiFi XP Temperature Ablation Catheter | Boston Scientific Corporation San Jose, CA 95134 |
Manufacturing change of the final electrical inspection test method. |
| P020045/S056 7/9/14 |
Freezor Cardiac CryoAblation System | Medtronic CryoCath LP Quebec, Canada H9R 5Z8 |
Addition of an inspection procedure for the Low Pressure Regulator during manufacturing, as well as the replacement of an analog pressure gauge used during installation and maintenance with a digital one. |
| P020045/S058 7/25/14 |
FREEZOR CARDIAC CRYOABLATION CATHETER, XTRA SURGICAL CRYOABLATION CATHETER, MAX SURGICAL CARDIAC CRYOABLATION CATHETER-Coaxial Umbilical Cable | Medtronic CryoCath LP Mounds View, MN 55112 |
Alternate supplier for connectors and connector fittings and acceptance of an alternate adhesive curing process. |
| P030005/S111 7/8/14 |
INVIVE, CONTAK RENEWAL, INTUA CRT-PACEMAKERS | Boston Scientific St. Paul, MN 55112 |
Add a functionally equivalent sterilization chamber; 2) add a third Abator to be used with the additional sterilizer; and 3) include sterilizer chamber enhancements required for the existing and additional sterilizer chambers. |
| P030005/S112 7/30/14 |
INVIVE CRT-P, INTUA CRT-P |
Boston Scientific Corporation St. Paul, MN 55112 |
Change in the Bioburden sampling frequency in the Clonmel and St Paul facilities for the devices. |
| P030009/S079 7/31/14 |
Integrity Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Changes to the sub-assembly manufacturing process. |
| P030017/S200 7/11/14 |
Precision Spectra™ Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Neuromodulation Valencia, CA 91355 |
Alternate capacitor supplier. |
| P030019/S020 7/8/14 |
Staarvisc, Optivisc, NuVisc, Anikavisc Sodium Hyaluronate | Anika Therapeutics, Inc. Bedford, MA 01730 |
Change to the syringe residual solvent testing from a supplier’s contract laboratory to the supplier’s in-house facility for Anika’s ophthalmic devices. |
| P030019/S021 7/25/14 |
Orthovisc, High Molecular Weight Hyaluronan | Anika Therapeutics, Inc. Bedford, MA 01730 |
Changes in the manufacturing equipment. |
| P030035/S122 7/9/14 |
ANTHEM RF CRT-PS | St. Jude Medical Sylmar, CA 91342 |
Modify the Device Post Sterilization Test (DPST) at ATE for the RF telemetry of the devices. |
| P030052/S015 7/16/14 |
UroVysion Bladder Cancer Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Modify the validated test method MDP00644 “Fragmented DNA Agarose Gel Electrophoresis” of the manufacturing process of Vysis ALK Break Apart FISH Probe Kit, PathVysion HER-2 DNA Probe Kit and UroVysion Bladder Cancer Kit. |
| P030053/S018 7/30/14 |
Mentor MemoryGel Silicone Gel-Filled Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to remove the in process Gel cohesion test that is performed during the manufacture of the Gel that is used to fill the Mentor MemoryGel Silicone Gel-Filled Breast Implants at Mentor’s Irving, Texas facility. |
| P030054/S271 7/10/14 |
Promote+, Promote Quadra, Unify, Unify Quadra, Unify Assura, and Quadra Assura Families of CRT-D Devices | St. Jude Medical, Sylmar, CA 91342 |
Change in the temperature cycling range for hybrid assemblies. |
| P030054/S272 7/18/14 |
Quadra Assura, Unify, Unify Assura, and Unify Quadra families of CRT-D Devices |
St. Jude Medical, Sylmar, CA 91342 |
Modification to the connector reinforcement process for hybrid assemblies. |
| P040002/S050 7/7/14 |
AFX Endovascular AAA System | Endologix, Inc. Irvine, CA 92618 |
Alternate supplier for the laser welding process for the delivery system inner core subassemblies. |
| P040002/S051 7/11/14 |
AFX Endovascular AAA System | Endologix, Inc. Irvine, CA 92618 |
Alternate polytetrafluoro- ethylene (PTFE) resin. |
| P040002/S052 7/9/14 |
AFX Endovascular AAA System | Endologix, Inc. Irvine, CA 92618 |
Alternate method for the heat-shrink process. |
| P040020/S054 7/16/14 |
AcrySof Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Addition of an alternate component supplier. |
| P040024/S075 7/1/14 |
Restylane, Perlane, Restylane-L, and Perlane-L Injectable Gels | Valeant Pharmaceuticals North America Bridgewater, NJ 08807 |
Introduction of an intermediate storage system (ISS) in the manufacturing process used in Factory 2. |
| P040027/S034 7/2/14 |
VIATORR TIPS Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center. |
| P040027/S035 7/2/14 |
VIATORR® TIPS Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>. |
| P040027/S036 7/2/14 |
VIATORR TIPS Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Updated hardware and software for FTIR spectrophotometer computers. |
| P040027/S037 7/2/14 |
VIATORR® TIPS Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer. |
| P040037/S066 7/2/14 |
VIABAHN Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center. |
| P040037/S067 7/2/14 |
VIABAHN® Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>. |
| P040037/S068 7/2/14 |
VIABAHN Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Updated hardware and software for FTIR spectrophotometer computers. |
| P040037/S069 7/2/14 |
VIABAHN® Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer. |
| P040037/S070 7/31/14 |
GORE VIABAHN Endoprosthesis and VIABAHN with Heparin Bioactive Surface | W.L. Gore & Associates Phoenix, AZ 85085 |
Automation of the presentation and cutting process for catheter manufacturing and removal of related inspections. |
| P040043/S063 7/2/14 |
TAG Thoracic Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center. |
| P040043/S064 7/2/14 |
TAG® Thoracic Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>. |
| P040043/S065 7/2/14 |
TAG Thoracic Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Updated hardware and software for FTIR spectrophotometer computers. |
| P040043/S066 7/2/14 |
TAG® Thoracic Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer. |
| P040045/S045 7/23/14 |
VISTAKON Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Add a second supplier for the senofilcon A monomer used for manufacturing VISTAKON (senofilcon A) brand contact lenses. |
| P040047/S036 7/16/14 |
Coaptite Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Changes to the sterilization process for the Coaptite Injectable Implant. |
| P050006/S039 7/2/14 |
HELEX Septal Occluder | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center. |
| P050006/S040 7/2/14 |
HELEX® Septal Occluder | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>. |
| P050006/S041 7/2/14 |
HELEX Septal Occluder | W.L. Gore & Associates Phoenix, AZ 85085 |
Updated hardware and software for FTIR spectrophotometer computers. |
| P050006/S042 7/2/14 |
HELEX® Septal Occluder | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer. |
| P050047/S039 7/9/14 |
Juvéderm Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Removal of an in-process control test used during the manufacture of Juvéderm Hyaluronate Gel Implants. |
| P050047/S041 7/30/14 |
Juvederm Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Change in the incoming inspection procedure for the Sodium Hyaluronate (NaHA) raw material. |
| P060001/S021 7/1/14 |
Protégé GPS and Protégé RX Carotid Stent System | ev3 Inc. Plymouth, MN 55441 |
Change from a manual to an automated stent cleaning process. |
| P060006/S063 7/18/14 |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
Changing the manual inspection of a component weld to a semi-automated inspection. |
| P060027/S067 7/16/14 |
Paradym CRT-D, Paradym RF, CRT-D, Paradym RF CRT-D |
Sorin CRM USA, Inc Arvada, CO 80004 |
Change to the in-process verifications for tantalum capacitors used in the devices. |
| P060040/S037 7/17/14 |
Thoratec® HeartMate II® LeftVentricular Assist System | Thoratec Corporation Pleasanton, CA 94588 |
Manufacturing process changes to the printed circuit board (PCB) of the device controller. |
| P070008/S052 7/11/14 |
Corox OTW, CELERITY Leads | Biotronik, Inc. Lake Oswego, OR 97035 |
Additional supplier for the conductor wires used in the manufacture of the leads. |
| P080025/S072 7/2/14 |
SNS Bowel Verify Screening Trialing Systems (including Temporary Leads) |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Update to the process flow at the IC Supplier. |
| P080025/S073 7/3/14 |
SNS Bowel, SNS Bowel Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Manufacturing change associated with incoming inspection activities. |
| P080025/S075 7/30/14 |
Medtronic Verify External Neurostimulator (ENS) | Medtronic Neuromodulation Minneapolis, MN 55432 |
Acceptance to expand the manufacturing acceptance criterion. |
| P090012/S009 7/7/14 |
MelaFind | MELA Sciences Incorporated Irvington, NY 10533 |
Added 3rd Party operating system installation software to version registry; and Deployment of new software build and installation workstations. |
| P090013/S144 7/11/14 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Supplier change and specification update to p(ETFE) used in Medtronic CRDM lithium-organic electrolyte batteries. |
| P090013/S145 7/8/14 |
CapSureFix MRI Lead | Medtronic, Inc. Mounds View MN, 55112 |
Add a helix linearity inspection at the final functional inspection and a helix linearity fixture to facilitate this linearity inspection. |
| P090013/S146 7/16/14 |
CAPSUREFIX MRI SURESCAN LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of an equivalent sterilizer and aerator. |
| P090022/S023 7/9/14 |
SOFTEC HD Intraocular Lenses | Lenstec, Inc. Saint Petersburg, FL 33716 |
Add three component washers for the use in the final clean area and inspection department to reduce bioburden and endotoxin of the intraocular lenses. |
| P090026/S011 7/7/14 |
Access Hybritech p2PSA reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Modification to the Quality Control prefill and postfill reagent pack procedures. |
| P090031/S002 7/8/14 |
Staarvisc, Optivisc, NuVisc, Anikavisc Sodium Hyaluronate | Anika Therapeutics, Inc. Bedford, MA 01730 |
Change to the syringe residual solvent testing from a supplier’s contract laboratory to the supplier’s in-house facility for Anika’s ophthalmic devices. |
| P100009/S006 7/16/14 |
MitraClip System | Abbott Vascular Menlo Park, CA 94025 |
Second supplier, a change in the heat treatment process and establishment of a defined range of acceptable raw material hardness for the Actuator Coupler of the MitraClip Clip Delivery System. |
| P100010/S036 7/2/14 |
Artic Front® and Artic Front Advance™ | Medtronic, Cryocath LP Mounds View, MN 55112 |
New supplier, inspection change, and minor updates to the specification of the bellows component. |
| P100010/S038 7/9/14 |
Arctic Front CryoCatheter System | Medtronic CryoCath LP Quebec, Canada H9R 5Z8 |
Addition of an inspection procedure for the Low Pressure Regulator during manufacturing, as well as the replacement of an analog pressure gauge used during installation and maintenance with a digital one. |
| P100010/S040 7/25/14 |
ARTIC FRONT CYROABLATION CATHETER, ARTIC FRONT ADVANCE CRYOABLATION CATHETER | Medtronic CryoCath LP Mounds View, MN 55112 |
Alternate supplier for connectors and connector fittings and acceptance of an alternate adhesive curing process. |
| P100026/S019 7/9/14 |
Neuropace RNS System | NeuroPace, Inc. Mountain View, CA 94043 |
Use a replacement detergent to clean certain parts. |
| P100042/S003 7/7/14 |
Aptima® HPV Assay | Gen-Probe Incorporated San Diego, CA 92121 |
Change to revise an internal control QC release test specification for the Aptima® HPV Assay. |
| P110002/S007 7/23/14 |
LDR Spine Mobi-C Cervical Disc Prosthesis for use at One Level | LDR Spine USA Inc. Austin, TX 78750 |
Add back-up equipment for the machining of the Mobi-C superior and inferior endplates. |
| P110009/S007 7/23/14 |
LDR Spine Mobi-C Cervical Disc Prosthesis for use at Two Levels | LDR Spine USA Inc. Austin, TX 78750 |
Add back-up equipment for the machining of the Mobi-C superior and inferior endplates. |
| P110012/S006 7/16/14 |
Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Modify the validated test method MDP00644 “Fragmented DNA Agarose Gel Electrophoresis” of the manufacturing process of Vysis ALK Break Apart FISH Probe Kit, PathVysion HER-2 DNA Probe Kit and UroVysion Bladder Cancer Kit. |
| P110013/S043 7/31/14 |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Changes to the sub-assembly manufacturing process. |
| P110023/S008 7/2/14 |
EverFlex Self-Expanding Peripheral Stent System | ev3 Inc. Plymouth, MN 55441 |
Allow internal production of a braid component for the EverFlex outer catheter. |
| P110023/S009 7/1/14 |
EverFlex Self-Expanding Peripheral Stent System | ev3 Inc. Plymouth, MN 55441 |
Change from a manual to an automated stent cleaning process. |
| P110033/S010 7/30/14 |
Juvederm Voluma XC | Allergan Goleta, CA 93117 |
Change in the incoming inspection procedure for the Sodium Hyaluronate (NaHA) raw material. |
| P120005/S022 7/10/14 |
Dexcom G4 PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Change to the conditioning step of manufacturing the sensor wire subcomponent of the G4 Sensor. The G4 Sensor is a component of the G4 PLATINUM Continuous Glucose Monitoring System. |
| P120005/S023 7/14/14 |
Dexcom G4 PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Changes to the shipping and storage temperature range specifications for two reagents used in the manufacture of the device. |
| P120005/S024 7/16/14 |
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Manufacturing process change for the sensor layer deposition process for the G4 PLATINUM Sensor. The G4 PLATINUM Sensor is a component of the Dexcom G4™ PLATINUM Continuous Glucose Monitoring System. |
| P120005/S025 7/24/14 |
Dexcom G4 PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Change in the manufacturing process of the transmitter packaging tray to increase mold capacity at their supplier. The transmitter is a component of the Dexcom G4 PLATINUM Continuous Glucose Monitoring System. |
| P120010/S025 7/2/14 |
MiniMed 530G System | Medtronic MiniMed Inc. Northridge, CA 91325 |
Change in the manufacturing process for the EnliteTM Glucose Sensor (Model Numbers: MMT-7008A, MMT-7008B) to add a new sensor fabrication configuration to include a 48-up sensor mask. The EnliteTM Glucose Sensor is a component of the MiniMed 530G System. |
| P120010/S027 7/24/14 |
MiniMed 530G System | Medtronic MiniMed Inc. Northridge, CA 91325 |
Change in the concentration of a raw material used during manufacture of the EnliteTM Glucose Sensor (MMT-7008) of the MiniMed 530G System and SofTM Glucose Sensor (MMT-7002, MMT-7003) of the Paradigm® REAL-Time System and Paradigm® REAL-Time Revel System. |
| P120010/S028 7/22/14 |
MiniMed 530G System | Medtronic MiniMed Inc. Northridge, CA 91325 |
Change to the needle hub assembly tooling which is used in the manufacture of the Enlite Sensor (MMT-7008). The Enlite Sensor (MMT-7008) is a component of the MiniMed 530G System. |
| P130006/S006 7/2/14 |
VIABAHN Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of Fourier Transform Infrared Spectroscopy, Bacterial Endotoxin Testing, Heavy Metals as Lead (HMAL) and Non-Volatile Residue (NVR) testing in the East Coast Testing Center. |
| P130006/S007 7/2/14 |
VIABAHN® Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an alternate bioburden extraction method and updating existing documents to allow for use of alternative/ additional organism strains and/or removal of specific microorganism strain designations and updated nomenclature in accordance with USP <61> and USP <62>. |
| P130006/S008 7/2/14 |
VIABAHN Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Updated hardware and software for FTIR spectrophotometer computers. |
| P130006/S009 7/2/14 |
VIABAHN® Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Implementation of an additional moisture analyzer and implementation of additional functionality of the analyzer. |
| P130006/S010 7/31/14 |
GORE VIABAHN Endoprosthesis and VIABAHN with Heparin Bioactive Surface | W.L. Gore & Associates Phoenix, AZ 85085 |
Automation of the presentation and cutting process for catheter manufacturing and removal of related inspections. |
