Summary of PMA Originals & Supplements Approved
- Originals: 4
- Supplements: 69
Summary of PMA Originals Under Review
- Total Under Review: 61
- Total Active: 29
- Total On Hold: 32
Summary of PMA Supplements Under Review
- Total Under Review: 571
- Total Active: 417
- Total On Hold: 154
Summary of All PMA Submissions
- Originals: 4
- Supplements: 93
Summary of PMA Supplement PMA Approval/Denial Decision Times
- Number of Approvals: 69
- Number of Denials: 0
- Average Days Fr Receipt to Decision (Total Time): 120.1
- FDA Time: 100.3 Days
- MFR Time: 19.8 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P110024 3/6/15 |
ResQCPR System | Advanced Circulatory Systems, Inc. Roseville, MN 55113 |
Approval for the ResQCPR System. This device is indicated for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest. |
P130013 3/13/15 |
WATCHMAN LAA Closure Technology | Boston Scientific Corporation St. Paul, MN 55311 |
Approval for the WATCHMAN LAA Closure Technology. This device is indicated to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation who: 1) Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2- VASc scores and are recommended for anticoagulation therapy; 2) Are deemed by their physicians to be suitable for warfarin; and 3) Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin. |
P130014 3/30/15 |
Adherus® AutoSpray Dural Sealant | HyperBranch Medical Technology, Inc. Durham, NC 27713 |
Approval for the Adherus AutoSpray Dural Sealant. This device is indicated for use in patients who are 13 years of age and older, as an adjunct to standard methods of dural repair, such as when using sutures, to provide watertight closure during cranial procedures. |
P140003 3/23/15 |
Impella 2.5 System | Abiomed, Inc. Danvers, MA 01923 |
Approval for the Impella. This device is indicated for: The Impella 2.5 System is a temporary (≤ 6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P830055/S155 3/25/15 Special |
LCS® Total Knee System | Depuy Orthopaedics, Inc. Warsaw, IN 46581 |
Adding a manual check of the inlet RO water flow into Tank 7 to ensure that additional orders are not processed by the system when the flow rate is below the 3 gallon per minute requirement. |
P850048/S040 3/20/15 135-Day |
Access Hybritech PSA Assay | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of an alternate vendor of the polypropylene resin used to manufacture the UniCel Dxl reaction vessels. |
P860047/S029 3/3/15 Real-Time |
OcuCoat® 2% Hydroxypropyl- methylcellulose (HPMC) Solution |
Bausch & Lomb Inc. Irvine, CA 92688 |
Approval to replace the 25 gauge cannula that is packaged with the 1 mL OcuCoat product with a 23 gauge cannula. |
P910073/S129 3/19/15 180-Day |
ENDOTAK RELIANCE™ /S, ENDOTAK RELIANCE™ G/SG, ENDOTAK RELIANCE™ 4-SITE | Boston Scientific St. Paul, MN 55112 |
Approval for changing from Oxyfume to 100% Ethylene Oxide sterilization and updated labeling. |
P930014/S076 3/10/15 Real-Time |
Acrysof® Aspheric UV Absorbing Intraocular Lens (IOL) | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for the AcrySof® Aspheric UV Absorbing Intraocular Lens (IOL) Model SA60WF. The device, as modified, will be marketed under the trade name AcrySof® Aspheric UV Absorbing Intraocular Lenses (IOLs) and is indicated for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag. |
P930029/S047 3/5/15 Real-Time |
Atakr Radiofrequency Catheter Ablation (RFCA) Systems | Medtronic, Inc. Mounds View, MN 55112 |
Approval for revised specification, manufacturing inspection criteria and associated measurement fixture for the in-process inspection of the distal curve range of the RF Contactr ablation catheters. |
P930029/S048 3/5/15 Real-Time |
Atakr Radiofrequency Catheter Ablation (RFCA) Systems | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changes to labeling and packaging for specific accessories (i.e., cables and foot switch) used with the Medtronic Atakr RFCA Systems. |
P950037/S142 3/19/15 180-Day |
Entovis DR-T, Entovis DR, Entovis SR-T, Entovis SR, Eluna 8 DR-T ProMRI, Eluna 8 DR ProMRI, Eluna 8 SR-T ProMRI and Eluna 8 SR ProMRI Permanent Implantable Pulse Generators, Setrox S 53, Setrox S 60, Safio S 53 and Safio S 60 Drug-Eluting Permanent Right Ventricular or Right Atrial Pacemaker Electrodes and ICS 3000/Renamic Programmers (Software 1403.U) |
Biotronik, INC. 6024 Jean Road Lake Oswego, OR 97035 |
Approval for the removal of the scan location restrictions for the ProMRI pacemaker system as well as updates to the ICS 3000/ Renamic Programmer Software (1403.U) for the devices. |
P950039/S026 3/2/15 180-Day |
ThinPrep 5000 Processor | Hologic, Inc. Marlborough, MA 01752 |
Approval for ThinPrep 5000 Processor. |
P970003/S176 3/4/15 Real-Time |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Approval for an update to the longevity manufacturing requirement associated with the Model 102/102R and Model 105 Generators. |
P970038/S029 3/20/15 135-Day |
Access Hybritech Free PSA Reagent/ Calibrator Kit | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of an alternate vendor of the polypropylene resin used to manufacture the UniCel Dxl reaction vessels. |
P970053/S015 3/30/15 180-Day |
Nidek EC-5000 Excimer Laser | Nidek Co., Ltd. Gamagori, Aichi Japan 443-0038 |
Approval for the a new 1 kHz eyetracker, which replaces the original 200 Hz eyetracker used with the EC-5000 Excimer Laser. This change also includes modification to the associated camera and software as well as the Infrared Red (IR) illumination. This device is indicated for topography-assisted laser- assisted in-situ keratomileusis (lasik) treatment using the final fit™ custom ablation treatment planning software for the reduction or elimination of myopic refractive errors from -1.0 to – 4.0 D of sphere with astigmatic refractive errors from ≥-0.5 to -2.0 D at the spectacle plane; in patients 21 years of age or older; and, in patients with documented stability of manifest refraction over the prior year, demonstrated by a change in MRSE not greater than ±0.5 D. |
P980016/S521 3/30/15 180-Day |
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD |
Medtronic Inc. Mounds View, MN 55112 |
Approval for the D453 IC to be used in the devices. |
P980035/S374 3/19/15 180-Day |
Advisa SR MRI SureScan, Advisa SR MRI and Advisa DR MRI Software Application Model 9995 Update | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Advisa SR MRI A3SR01 Implantable Pulse Generator in combination with the CapSureFix MRI SureScan Lead Model 5086MRI to be marketed as the Advisa SR MRI SureScan. In addition, you requested approval for modifications to the Advisa SR MRI and Advisa DR MRI Software Application Model 9995. |
P980037/S045 3/31/15 Real-Time |
AngioJet® Rheolytic™ Thrombectomy System | Boston Scientific Corporation Minneapolis, MN 55433 |
Approval for the addition of an inrush current limiter to the AngioJet Ultra Console. |
P980040/S056 3/17/15 180-Day |
TECNIS® Toric 1-Piece Intraocular Lens (IOL) with the TECNIS iTec Preloaded Delivery System | Abbott Medical Optics, Inc Santa Ana, CA 92705 |
Approval for a change to the packaging of the Model Series ZCT Intraocular Lenses (IOL) from a wheelcase configuration to a preloaded packaging configuration/ delivery system. The preloaded lens models will be branded under the name “TECNIS® Toric 1-Piece IOL with TECNIS iTec Preloaded Delivery System, Models PCT150, PCT225, PCT300 and PCT400.” |
P980041/S030 3/20/15 135-Day |
Access AFP Immunoassay System | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of an alternate vendor of the polypropylene resin used to manufacture the UniCel Dxl reaction vessels. |
P980044/S024 3/31/15 180-Day |
SUPARTZ® | Seikagaku Corporation Tokyo, Japan 100-0005 |
Approval for revisions of the Instructions for Use (IFU) and the Patient Information (PI) for SUPARTZ as follows: 1) Revision in the instructions for use (IFU) and patient information (PI) of the statement, “The safety and effectiveness of repeat treatment cycles of SUPARTZ have not been established.” to “The effectiveness of repeat treatment cycles of SUPARTZ has not been established.”; and 2) Insertion in the IFU and PI of the statements, “Adverse experience data from the literature contain no evidence of increased safety risk relating to retreatment with SUPARTZ. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle.” |
P990040/S020 3/24/15 Real-Time |
TruFill N-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval for changing the supplier and the material for the n-Butyl Cyanoacrylate (n-BCA) caps. |
P990074/S031 3/13/15 180-Day |
Natrelle Saline-Filled Breast Implants | Allergan Incorporated Goleta, CA 93117 |
Approval for the following packaging and manufacturing changes: 1) Modification of the primary inner and outer tray packaging to include two finger tabs; 2) Modification of the outer tray to include two cavities; 3) A change of the polycarbonate tray material to GEOX Peerex® 51 PC polycarbonate film to be supplied by Prent Thermoforming; 4) Primary lid packaging that is larger with blue ink arrows; 5) Larger secondary packaging boxes to house the larger trays; 6) A change to a separate tamper evident label, i.e., the product labels no longer serve as a tamper evident label; and 7) Changes to the heat sealing process (new parameters: temperature = 236-256oF, dwell time = 4.9-6.9 s, pressure = 60-80 psi). |
P000009/S060 3/19/15 180-Day |
BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD’S | Biotronik, INC. 6024 Jean Road Lake Oswego, OR 97035 |
Approval for the removal of the scan location restrictions for the ProMRI pacemaker system as well as updates to the ICS 3000/ Renamic Programmer Software (1403.U) for the devices. |
P000025/S081 3/11/15 Real-Time |
MED-EL COMBI 40+ Cochlear Implant System | MED-EL Corporation Durham, NC 27713 |
Approval for the DL-Coil, an external audio processor coil for use with the MED-EL cochlear implant, as part of the COMBI 40+ Cochlear Implant System. |
P010012/S383 3/19/15 180-Day |
ACUITY SPIRAL LEADS | Boston Scientific St. Paul, MN 55112 |
Approval for changing from Oxyfume to 100% Ethylene Oxide sterilization and updated labeling. |
P010021/S025 3/11/15 135-Day |
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator | Ortho-Clinical Diagnostics, Incorporated Rochester, NY 14626 |
Approval for changes to the QC testing for the raw material anti-HCV positive plasma. |
P010031/S485 3/30/15 180-Day |
Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D | Medtronic Inc. Mounds View, MN 55112 |
Approval for the D453 IC to be used in the devices. |
P010032/S090 3/4/15 Real-Time |
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM | St. Jude Medical Plano, TX 75024 |
Approval for a design change to the stylet models that are used with SJM SCS systems; specifically, coating the stylets with a PFOA-free PTFE, resulting in Generation 3 of the stylets. This supplement also requested approval for a manufacturing change to tighten the tolerances on the tooling mandrel used to manufacture the associated lead models. |
P010032/S094 3/24/15 Real-Time |
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM | St. Jude Medical Plano, TX 75024 |
Approval for minor design changes to the 8-Channel Adapter (Models 2311 and 2316) to introduce a new 8-Channel Adapter (Models 2321 and 2326) for the Spinal Cord Stimulation System. The new 8-Channel Adapter is intended to connect a compatible 8-channel Boston Scientific lead or extension to a compatible St. Jude Medical implantable pulse generator. |
P010047/S037 3/16/15 180-Day |
ProGel Pleural Air Leak Surgical Sealant and ProGel Extended Applicatory Spray Tip | Neomend, Inc. 60 Technology Drive Irvine, CA 92618 |
Approval to extend enrollment by 13 months to complete enrollment in the PAS to the post-approval study protocol. |
P020050/S020 3/31/15 Real-Time |
Wavelight Ex500 Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for a firmware fix. |
P020056/S018 3/5/15 180-Day |
Natrelle Silicone-Filled Brest Implants | Allergan Incorporated Irvine, CA 92612 |
Approval for updated labeling to include 10 year data from the Core Clinical Study. |
P020056/S027 3/13/15 180-Day |
Natrelle Silicone-Filled Breast Implants | Allergan Incorporated Goleta, CA 93117 |
Approval for the following packaging and manufacturing changes: 1) Modification of the primary inner and outer tray packaging to include two finger tabs; 2) Modification of the outer tray to include two cavities; 3) A change of the polycarbonate tray material to GEOX Peerex® 51 PC polycarbonate film to be supplied by Prent Thermoforming; 4) Primary lid packaging that is larger with blue ink arrows; 5) Larger secondary packaging boxes to house the larger trays; 6) A change to a separate tamper evident label, i.e., the product labels no longer serve as a tamper evident label; and 7) Changes to the heat sealing process (new parameters: temperature = 236-256oF, dwell time = 4.9-6.9 s, pressure = 60-80 psi). |
P030008/S018 3/31/15 Real-Time |
Wavelight Ex500 Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for a firmware fix. |
P030017/S206 3/31/15 |
Precision Spectra Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Valencia, CA 91355 |
Adding an alternate qualified supplier for the grooved Coil Connector that is used in the assembly of the Precision Spectra Implantable Pulse Generator (IPG). |
P030031/S065 3/18/15 180-Day |
ThermoCool Catheters For the Treatment of Type I Atrial Flutter and Atrial Fibrillation | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for modification of the ThermoCool SmartTouch shaft and sensor. |
P030056/S008 3/10/15 180-Day |
ADVIA Centaur® HCV ReadyPack Reagents, ADVIA Centaur® HCV Quality Control Materials | Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 |
Approval for the claim to test a pediatric population with the FDA approved ADVIA Centaur HCV ReadyPack Reagents and ADVIA Centaur HCV Quality Control Materials. The device, as modified, will be marketed under the trade name ADVIA Centaur HCV ReadyPack Reagents and ADVIA Centaur HCV Quality Control Materials and is indicated for: ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur HCV (aHCV) assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human pediatric (18 months – 21 years) and adult serum and plasma (EDTA, lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP systems. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection. ADVIA Centaur CP system: The ADVIA Centaur HCV (aHCV) assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human pediatric (18 months – 21 years) and adult serum and plasma (EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP system. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection. |
P040013/S020 3/9/15 Special |
Gems 21s (Growth-Factor Enhanced Matrix) | Luitpold Pharmaceuticals, Inc. Norristown, PA 19403 |
Approval for final patient labeling. |
P040036/S048 3/18/15 180-Day |
ThermoCool Catheters For the Treatment of Ventricular Tachycardia | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for modification of the ThermoCool SmartTouch shaft and sensor. |
P040044/S062 3/3/15 Real-Time |
Mynx Ace Vascular Closure Device (Mynx Ace) | Access Closure, Inc. Santa Clara, CA 95054 |
Approval for minor modifications to the Mynx Ace device that involve Button 3, the packaging tray, and Instructions for Use (IFU) associated with Button 3. |
P040046/S009 3/13/15 180-Day |
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants |
Allergan Incorporated Goleta, CA 93117 |
Approval for the following packaging and manufacturing changes: 1) Modification of the primary inner and outer tray packaging to include two finger tabs; 2) Modification of the outer tray to include two cavities; 3) A change of the polycarbonate tray material to GEOX Peerex® 51 PC polycarbonate film to be supplied by Prent Thermoforming; 4) Primary lid packaging that is larger with blue ink arrows; 5) Larger secondary packaging boxes to house the larger trays; 6) A change to a separate tamper evident label, i.e., the product labels no longer serve as a tamper evident label; and 7) Changes to the heat sealing process (new parameters: temperature = 236-256oF, dwell time = 4.9-6.9 s, pressure = 60-80 psi). |
P050023/S081 3/19/15 180-Day |
ICS 3000/Renamic Programmers (Software 1403.U) | Biotronik, INC. 6024 Jean Road Lake Oswego, OR 97035 |
Approval for the removal of the scan location restrictions for the ProMRI pacemaker system as well as updates to the ICS 3000/ Renamic Programmer Software (1403.U) for the devices. |
P050038/S023 3/16/15 180-Day |
ARISTA AH FlexiTip XL-R for Arista AH, Absorbable Hemostatic Particles | C. R. Bard Incorporated Woburn, MA 01801 |
Approval for the line extension of the FLEXITIP XL Applicator Family to include the FLEXITIP XL-R applicator. The modification is based upon the current applicator design but now includes an additional outer stainless steel tubing to create a rigid (XL-R) portion of the applicator tip. In addition, approval for revision of the instructions for use of the ARISTA AH product labeling in order to inform users of use of the new applicator during endoscopic/ laparoscopic uses. |
P060028/S005 3/2/15 180-Day |
MemoryShape™ Breast Implants | Mentor Worldwide, LLC Santa Barbara, CA 93111 |
Approval for a change to a “low bleed” patch design for MemoryShape Breast Implants. |
P060037/S032 3/10/15 135-Day |
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee | Zimmer, Inc. Warsaw, IN 46581 |
Approval for a change in water quality monitoring. |
P060039/S065 3/11/15 135-Day |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval an update to the manufacturing process of the blue tubing used in the construction of the lead to replace Tygon with Viton. |
P070008/S057 3/19/15 180-day |
ICS 3000/Renamic Programmers (Software 1403.U) | Biotronik, INC. 6024 Jean Road Lake Oswego, OR 97035 |
Approval for the removal of the scan location restrictions for the ProMRI pacemaker system as well as updates to the ICS 3000/ Renamic Programmer Software (1403.U) for the devices. |
P070026/S024 3/18/15 180-Day |
Ceramax Ceramic Hip System | Depuy, Inc. Warsaw, IN 46581 |
Approval for the for the inclusion of the SUMMIT® POROCOAT® femoral prosthesis, the PINNACLE® 300 Series, Multi-Hole and Sector II acetabular shells and the Tamp Extractor manual surgical instrument for the newly enrolled patients study arm to the post-approval study protocol. |
P070026/S025 3/10/15 180-Day |
Depuy Ceramax Ceramic Total Hip System | Depuy, Inc. Warsaw, IN 46581 |
Approval of the following changes to the post-approval study for the device: patients with any of 5 different stems to participate to facilitate patient enrollment and removing acetabular shells from this PAS protocol. |
P070026/S026 3/12/15 180-Day |
Depuy Ceramax Ceramic Total Hip System | Depuy, Inc. Warsaw, IN 46581 |
Approval of the post-approval study protocol. |
P070026/S029 3/25/15 Special |
Ceramax® Ceramic Total Hip System | Depuy Orthopaedics, Inc. Warsaw, IN 46581 |
Adding a manual check of the inlet RO water flow into Tank 7 to ensure that additional orders are not processed by the system when the flow rate is below the 3 gallon per minute requirement. |
P080009/S004 3/23/15 180-Day |
Sedasys Computer‐Assisted Personalized Sedation System | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 |
Approval of the changes to the post-approval study protocol. |
P080009/S005 3/25/15 180-Day |
SEDASYS Computer-Assisted Personalized Sedation System | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 |
Approval of the changes to the post-approval study protocol. |
P080011/S035 3/11/15 180-Day |
Biofinity Energys Asphere, Biofinity XR Toric, and Biofinity XR Multifocal (comfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear |
CooperVision, Inc. Pleasanton CA 94588 |
Approval for a change in trade name for the Biofinity Energys Aspheric Lens and expanded powers for the Biofinity XR Toric and Biofinity XR Multifocal Lenses. The devices, as modified, will be marketed under the trade names Biofinity Energys Asphere, Biofinity XR Toric, and Biofinity XR Multifocal (comfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear and are indicated for: BIOFINITY Energys™ Asphere (comfilcon A) soft contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. BIOFINITY XR TORIC (comfilcon A) Soft Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 D and astigmatism corrections from -0.25 to -5.75 D. BIOFINITY XR MULTIFOCAL (comfilcon A) lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) with emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 D and with add powers from +0.05 to +4.00 D. The lenses may be worn by persons who exhibit astigmatism of 2.00 D or less that does not interfere with visual acuity. The BIOFINITY (comfilcon A) Soft (hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights and 7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of exteneded wear can be followed as determined by teh prescribing eye care professional. Eye care practitioners may prescribe the lens for frequent replacement wear, with cleaning, disinfecting, and scheduled replacements. |
P080030/S014 3/24/15 Real-Time |
Glaukos iStent® Trabecular Micro-Bypass Stent System | Glaukos® Corporation Laguna Hills, CA 92653 |
Approval to update the magnetic resonance imaging (MRI) information in the Instruction for Use and patient ID card of the iStent Trabecular Micro-Bypass Stent System. |
P090026/S014 3/20/15 135-Day |
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of an alternate vendor of the polypropylene resin used to manufacture the UniCel Dxl reaction vessels. |
P100005/S005 3/2/15 180-Day |
M-Vu Algorithm Engine | VuCOMP, Inc. Plano, TX 75093 |
Approval for M-Vu Algorithm Engine version 3.2.0.0. |
P100021/S045 3/25/15 Special |
Endurant Stent Graft System, Endurant (II/IIs) Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the addition of a manufacturing aid to be used during the thumbwheel assembly process. |
P100025/S008 3/5/15 180-Day |
BreathTek® UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation | Otsuka America Pharmaceutical, Incorporated Rockville, MD 20850 |
Approval for an amendment to the Drug Master File for the following changes: 1) Additional process development work for the purification process; 2) Validation of the purification process improvements; 3) Site transfer for the purification process; 4) Change to a specification of a starting material; 5. Additional sizes for the outer container and inner bags for the purification process; and 6) Updated stability information. |
P100026/S026 3/10/15 Real-Time |
Neuropace RNS® System | Neuropace, Inc Mountain View, CA 94043 |
Approval for a modification to the battery assembly to add additional carbon monoflouride (CFx) cathode material. |
P100034/S011 3/17/15 135-Day |
NovoTTF-100A System | Novocure Ltd. Haifa, Israel 31905 |
Approval for an alternate source of shrink coverage material used in the INE insulated transducer arrays |
P100034/S012 3/23/15 135-Day |
NovoTTF-lOOA System | Novocure Ltd. Haifa, Israel 31905 |
Approval for an additional supplier of 15V DC/DC Converter Component for Novo TTF-100A System |
P100047/S055 3/25/15 Special |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Approval for an additional independent inspection at final packaging. |
P110004/S011 3/17/15 Special |
NIRxcell CoCr Coronary Stent On Rx | Medinol, Ltd. Tel Aviv, Israel 6158101 |
Approval for a patient implant card. |
P110037/S016 3/26/15 Real-Time |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for software changes to the Total Aspiration and Dispense Monitoring (TADM) Tolerance Band Parameters for the cobas p 630 instrument for pipetting CAP/CTM CMV Controls. |
P110038/S009 3/6/15 180-Day |
Relay Thoracic Stent-Graft with Plus Delivery System | Bolton Medical, Inc. Sunrise, FL 33325 |
Approval to increase the rate of enrollment to a more acceptable rate in the post-approval study protocol. |
P110042/S043 3/13/15 180-Day |
EMBLEM S-ICD System | Boston Scientific Corporation St Paul, MN 55112 |
Approval for the EMBLEM S-ICD System. |
P120010/S056 3/20/15 Real-Time |
Minimed 530g System | Medtronic Minimed Northridge, CA 91325 |
Approval for additional manufacturing testing to be performed on a different version of a component used in the manufacture of the MiniMed 530G Insulin Pump MMT-551, MMT-751 that is part of the MiniMed 530G System. |
P130005/S006 3/18/15 Real-Time |
Diamondback 360 Coronary Orbital Atherectomy System (OAS) | Cardiovascular Systems, Inc. St. Paul, MN 55112 |
Approval for a change in the design of the flexible container system of the ViperSlide (lntralipid 10%) lubricant. |
P130021/S010 3/30/15 Panel-Track |
Medtronic CoreValve™ System (MCS),Trans-catheter Aortic Valve (TAV), CoreValve™ Evolut™, Delivery Catheter System (DCS), and Compression Loading System |
Medtronic CoreValve LLC Santa Rosa, CA 95403 |
Approval for the Medtronic CoreValve™ system. This device is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥15% risk of mortality at 30 days). |
P130026/S002 3/26/15 Special |
TactiCath Quartz Set | St. Jude Medical St. Paul, MN 55117 |
Approval for changes to the manufacturing process and an additional inspection associated with irrigation tubing. |
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 |
---|---|---|---|
P810002/S095 3/26/15 |
SJM Mechanical Heart Valves | St. Jude Medical, Inc. St. Paul, MN 55117 |
New method for leaflet substrate slicing. |
P810006/S059 3/20/15 |
CollaStat Absorbable Collagen Hemostatic Sponge, CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Addition of a new ethanol squeeze device to replace the hand squeezing process currently used during manufacture of the devices. |
P810006/S060 3/26/15 |
Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent – Microfibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Enhanced compressor configuration. |
P830061/S118 3/2/15 |
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P840001/S293 3/6/15 |
Spinal Cord Stimulation System | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Automate inspection of final device sealed tray package. |
P840001/S294 3/20/15 |
RESTORE, ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEAD | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Change the braided lead body cutting process. |
P840001/S295 3/27/15 |
Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems and Pisces, Specify and Vectris SCS Leads |
Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Transfer of incoming inspection activities for a number of components. |
P840062/S044 3/26/15 |
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Enhanced compressor configuration. |
P850010/S058 3/20/15 |
HeliStat, Helitene Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Addition of a new ethanol squeeze device to replace the hand squeezing process currently used during manufacture of the devices. |
P850010/S059 3/26/15 |
Helistat, Helitene Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Enhanced compressor configuration. |
P850064/S029 3/20/15 |
Life Pulse High Frequency Ventilator | Bunnell, Inc. Salt Lake City, UT 84115 |
Addition of an automated wire stripper. |
P850089/S113 3/2/15 |
CapSure SP Novus Lead, CapSure Z Novus Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P860003/S078 3/19/15 |
Therakos UVAR XTS and CELLEX Photopheresis Systems | Therakos Inc. Bridgewater, NJ 08807 |
Manufacturing process change for a component of the Therakos CELLEX Photopheresis Systems. |
P860004/S221 3/2/15 |
Medtronic SynchroMed Infusion System | Medtronic, Incorporated Neuromodulation Minneapolis, MN, 55432 |
Relocation of an external supplier’s manufacturing facility and the replacement of the current laser marking equipment. |
P860004/S222 3/3/15 |
Medtronic SynchroMed Infusion System | Medtronic, Incorporated Neuromodulation Minneapolis, MN, 55432 |
Update the cleaning process of the pump head components. |
P860004/S223 3/27/15 |
SynchroMed Infusion System | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Transfer of incoming inspection activities for a number of components. |
P890003/S327 3/2/15 |
CapSure VDD 2 Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P900033/S043 3/4/15 |
Integra Dermal Regeneration Template | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Qualification of a new product package sealing equipment for the Integra Dermal Regeneration Template, at the Plainsboro, New Jersey, Integra manufacturing facility. |
P910007/S048 3/26/15 |
ARCHITECT Total PSA | Abbott Laboratories Park, IL 60064 |
Changes in the precursor code for bovine serum and human prostate specific antigen with equivalent materials for the manufacture of the ARCHITECT Free PSA and Total PSA Calibrators, Controls, and Secondary Calibrators. |
P920015/S148 3/3/15 |
Sprint Quattro Lead | Medtronic Incorporated Mounds View, MN 55112 |
Implement a new method to apply adhesive to slits in the models. |
P920015/S149 3/2/15 |
Sprint Quattro Lead, Subcutaneous Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P920047/S077 3/24/15 |
Blazer II, Blazer II HTD, Blazer Prime HTD Ablation Catheters | Boston Scientific Corporation St. Paul, MN 55112 |
New traceability and tracking system at the Heredia, Costa Rica location. |
P930014/S078 3/19/15 |
AcrySof® Intraocular | Alcon Research, Ltd. Fort Worth, TX 76134 |
Two alternate polypropylene resins, Basell PD702 and Total M3766. |
P930038/S075 3/26/15 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical Plymouth, MN 55442 |
Alternate dose audit sterility testing vendor. |
P930039/S125 3/2/15 |
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, Vitatron Crystalline Active Fixation Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P930039/S126 3/11/15 |
CapSureFix Novus Lead | Medtronic, Inc. Mounds View, MN 55112 |
Updates to procedures for torque testing at final functional inspection. |
P950005/S056 3/19/15 |
EZ Steer DS, Celsius Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Additional qualified supplier for extrusion and braiding processes. |
P950029/S103 3/17/15 |
Reply SR, Reply DR, Esprit SR, Esprit DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Addition of Automated Optical Inspection (AOI) in manufacturing assembly line for the devices. |
P950029/S104 3/19/15 |
Reply SR, Reply DR, Esprit SR, Esprit DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Add an alternate supplier for the glue used in the die attach process for the hybrids used in the devices. |
P960009/S217 3/6/15 |
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Automate inspection of final device sealed tray package. |
P960009/S218 3/20/15 |
Activa Deep Brain Stimulation Therapy System; DBS Leads | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Addition of an alternate material and component supplier. |
P960009/S221 3/27/15 |
Activa Deep Brain Stimulation (DBS) Therapy System | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Transfer of incoming inspection activities for a number of components. |
P960040/S343 3/1/15 |
INOGEN ICD, ORIGEN ICD, DYNAGEN ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier of the HV capacitor lids for the devices. |
N970003/S171 3/23/15 |
ADVANTIO™ Pacemaker; INGENIO™ Pacemaker; VITALIO™ Pacemaker | Boston Scientific Corporation St. Paul, MN 55112 |
Manufacture the battery feedthru subassembly used in the devices at the St. Paul facility. |
N970003/S172 3/27/15 |
ADVANTIO, INGENIO, VITALIO, FORMIO | Boston Scientific St. Paul, MN 55112 |
Addition of a deburring operation and additional monitoring during the manufacturing of case halves for the devices. |
P970004/S190 3/6/15 |
INTERSTIM THERAPY SYSTEM | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Automate inspection of final device sealed tray package. |
P970004/S192 3/26/15 |
Sacral Nerve Stimulation (SNS), Urinary Implantable Neurostimulator (INS) Interstim Family | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Manufacturing change affecting the component of an implantable neurostimulator (INS) used for the Medtronic Neuromodulation Sacral Nerve Stimulation (SNS) therapies. |
P970004/S193 3/27/15 |
InterStim Therapy System | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Transfer of incoming inspection activities for a number of components. |
P970051/S128 3/13/15 |
Cochlear Nucleus CI24RE Cochlear Implant, Cochlear Nucleus CI422 Cochlear Implant |
Cochlear Americas Centennial, CO 80111 |
Addition of the helium bombing, and removal of gross leak test for the Magnet Assembly. |
P980003/S057 3/24/15 |
Chilli II Cooled Ablation System | Boston Scientific Corporation St. Paul, MN 55112 |
New traceability and tracking system at the Heredia, Costa Rica location. |
P980006/S024 3/23/15 |
PureVision® Toric® and PureVision2® Toric Product Family | Bausch & Lomb Rochester, NY 14609 |
New optical comparator vision system. |
P980007/S039 3/26/15 |
ARCHITECT Free PSA | Abbott Laboratories Park, IL 60064 |
Changes in the precursor code for bovine serum and human prostate specific antigen with equivalent materials for the manufacture of the ARCHITECT Free PSA and Total PSA Calibrators, Controls, and Secondary Calibrators. |
P980016/S526 3/4/15 |
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, Inc. Mounds View, MN 55112 |
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices. |
P980016/S527 3/1/15 |
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 Incorporated Mounds View, MN 55112 |
Update the final visual inspection criteria for the hybrids used in the devices. |
P980016//S528 3/3/15 |
Evera S, Evera XT, Maximo, Protecta, Protecta XT, Secura, and Virtuoso II ICDs | Medtronic Inc. Mounds View, MN 55112 |
Updates to the integrated circuit test software and test process. |
P980016/S530 3/1/15 |
Brava, Brava Quad, Viva S, Viva XT, Viva Quad S, and Viva Quad XT CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Connector module inspection updates including the addition of inspection criteria specific to embedded fibers and the addition of a redundant inspection step verifying the presence of a radiopaque. |
P980016/S531 3/17/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic Inc. Mounds View, MN 55112 |
Changes to the capacitor manufacturing line. |
P980016/S532 3/11/15 |
Evera S DR, Evera S VR, Evera XT DR, and Evera XT VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Add new equipment for the Fill Hole Seal (FHS) and Button (BTN) welds which are used to hermetically seal the electrolyte fill port. |
P980016/S533 3/17/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing process for the capacitor case subassembly used in the devices. |
P980016/S534 3/19/15 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Merging two different electrical connector monitoring plans to establish one standard plan used for both the battery and capacitor electrical connectors. |
P980035/S411 3/4/15 |
Advisa DR IPG, Advisa DR MRI IPG , Relia IPG, Adapta, Versa, Sensia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices. |
P980035/S412 3/1/15 |
Advisa DR IPG, Advisa DR MRI IPG , Relia IPG, Adapta, Versa, Sensia IPG | Medtronic Incorporated Mounds View, MN 55112 |
Update the final visual inspection criteria for the hybrids used in the devices. |
P980035/S413 3/3/15 |
Advisa DR, Advisa DR MRI IPGs | Medtronic Inc. Mounds View, MN 55112 |
Updates to the integrated circuit test software and test process. |
P980049/S106 3/17/15 |
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR, Intensia VR ICD, Intensia DR |
Sorin CRM USA, Inc. Arvada, CO 80004 |
Addition of Automated Optical Inspection (AOI) in manufacturing assembly line for the devices. |
P980049/S107 3/13/15 |
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR, Paradym RF VR, Paradym RF DR, Intensia VR, Intensia DR |
Sorin CRM USA, Inc. Arvada, CO 80004 |
Use of additional electrical welding equipment in the manufacturing laboratory. |
P980049/S108 3/19/15 |
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR, Intensia VR, Intensia DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Add an alternate supplier for the glue used in the die attach process for the hybrids used in the devices. |
P980050/S098 3/2/15 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P990004/S026 3/17/15 |
SURGIFOAM Absorbable Gelatin Sponge, USP | Ethicon, Inc. Somerville, NJ 08876 |
Changes to the sampling frequency used for the in-process visual inspection, barcode scanning and vacuum testing performed on the SURGIFOAM packaging. |
P990004/S027 3/17/15 |
SURGIFOAM Absorbable Gelatin Sponge, USP | Ethicon, Inc. Somerville, NJ 08876 |
Optimization of a pouch packaging machine used for the manufacture of SURGIFOAM Absorbable Gelatin Sponge. |
P990025/S044 3/19/15 |
EZ Steer Nav, NaviStar Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Additional qualified supplier for extrusion and braiding processes. |
P990025/S045 3/23/15 |
EZ Steer Nav, NaviStar Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Adding a second supplier for the 1mm sensor component used in the catheter families. |
P000006/S041 3/4/15 |
Titan Inflatable Penile Prosthesis | Coloplast Corp Minneapolis, MN 55411 |
Implementing use of an additional cavity in an existing multi cavity mold. |
P000006/S042 3/5/15 |
Titan Inflatable Penile Prosthesis | Coloplast Corp Minneapolis, MN 55411 |
Implementing a modified preparation procedure for tubing. |
P000006/S043 3/5/15 |
Titan Inflatable Penile Prosthesis | Coloplast Corp Minneapolis, MN 55411 |
Change to the Exhaust Core Diameter dimension on the Titan Touch Pump Body Drawing. The change involves updating the Titan Touch Pump Body Drawing to reflect the measurements obtained using a consistent cut technique. |
P000037/S039 3/26/15 |
On-x Prosthetic Heart Valve | On-x Life Technologies, Inc. Austin, TX 78752 |
Additional X-Ray Machine. |
P010001/S011 3/25/15 |
Transcend Hip Articulation System | CeramTec GmbH Plochingen, Germany D-73207 |
Addition of cleaning equipment. |
P010012/S385 3/1/15 |
INOGEN CRT-D, ORIGEN CRT-D, DYNAGEN CRT-D |
Boston Scientific Corporation St. Paul, MN 55112 |
Alternate supplier of the HV capacitor lids for the devices. |
P010013/S062 3/19/15 |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Addition of an in-house assembly process for the Radio Frequency Controller component. |
P010015/S263 3/4/15 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices. |
P010015/S264 3/1/15 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P | Medtronic Incorporated Mounds View, MN 55112 |
Update the final visual inspection criteria for the hybrids used in the devices. |
P010015/S265 3/3/15 |
Consulta, Syncra, and Viva CRT-Ps | Medtronic Inc. Mounds View, MN 55112 |
Updates to the integrated circuit test software and test process. |
P010015/S267 3/2/15 |
Attain OTW Lead, Attain Bipolar OTW Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P010029/S022 3/12/15 |
EUFLEXXA (1% Sodium Hyaluronate) | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Proposed scale-up of manufacturing processes to increase product yield per lot for the EUFLEXXA product. |
P010030/S060 3/27/15 |
ZOLL LifeVest WCD 4000 | ZOLL Manufacturing Corporation Pittsburgh, PA 15238 |
Expansion of an electrical test procedure to cover additional components, implementation of a new work instruction, and addition of an independent visual verification step. |
P010031/S490 3/4/15 |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices. |
P010031/S491 3/1/15 |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic Incorporated Mounds View, MN 55112 |
Update the final visual inspection criteria for the hybrids used in the devices. |
P010031/S492 3/3/15 |
Brava, Brava Quad, Concerto, Consulta, Maximo, Protecta, Protecta XT, Viva Quad, Viva Quad, Viva S and Viva XT CRT-Ds | Medtronic Inc. Mounds View, MN 55112 |
Updates to the integrated circuit test software and test process. |
P010031/S493 3/1/15 |
Brava, Brava Quad, Viva S, Viva XT, Viva Quad S, and Viva Quad XT CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Connector module inspection updates. |
P010031/S495 3/17/15 |
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic Inc. Mounds View, MN 55112 |
Alternate manufacturing line for the triple assembly, Pin Trim, Capaciter Electrial connector placmentt, CEC Pin bend, laser condition, CEC Pin resistance spot weld CEC underfill and triple eval inspection: including incorportion automation for 2 process and modification Pin laser condition step. |
P010031/S496 3/11/15 |
Brava, Brava Quad, Viva S, Viva XT, Viva Quad S, and Viva Quad XT CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Add new equipment for the Fill Hole Seal (FHS) and Button (BTN) welds which are used to hermetically seal the electrolyte fill port. |
P010031/S497 3/17/15 |
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D. Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Update to the manufacturing process for the capacitor case subassembly used in the devices. |
P010031/S498 3/19/15 |
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Merging two different electrical connector monitoring plans to establish one standard plan used for both the battery and capacitor electrical connectors. |
P010068/S045 3/19/15 |
EZ Steer Nav DS Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Additional qualified supplier for extrusion and braiding processes. |
P010068/S046 3/23/15 |
EZ Steer NAV DS | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Adding a second supplier for the 1mm sensor component used in the catheter families. |
P020004/S111 3/31/15 |
GORE® EXCLUDER® AAA Endoprosthesis | W.L. Gore and Associates Flagstaff, AZ 860003 |
Use film materials manufactured by Gore’s approved supplier on an alternating manufacturing line for GORE TAG Endoprosthesis and the GORE EXCLUDER AAA Endoprosthesis. |
P020025/S068 3/24/15 |
Blazer Prime XP, Blazer II XP, IntellaTip MiFi XP Ablation Catheters | Boston Scientific Corporation St. Paul, MN 55112 |
New traceability and tracking system at the Heredia, Costa Rica location. |
P030005/S117 3/23/15 |
INVIVE™ CRT-P; INTUA™ CRT-P | Boston Scientific Corporation St. Paul, MN 55112 |
Manufacture the battery feedthru subassembly used in the devices at the St. Paul facility. |
P030015/S118 3/27/15 |
INVIVE, INTUA | Boston Scientific St. Paul, MN 55112 |
Addition of a deburring operation and additional monitoring during the manufacturing of case halves for the devices. |
P030017/S214 3/13/15 |
Precision Spectra Spinal Cord Stimulator System | Boston Scientific Neuromodulation Valencia, CA 91355 |
Upgrade to new battery test equipment. |
P030017/S215 3/25/15 |
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems | Boston Scientific Neuromodulation Valencia, CA 91355 |
Add a supplier of printed circuit board components. |
P030031/S066 3/19/15 |
EZ Steer, ThermoCool Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Additional qualified supplier for extrusion and braiding processes. |
P030031/S067 3/23/15 |
EZ Steer ThermoCool NAV, ThermoCool SF NAV | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Adding a second supplier for the 1mm sensor component used in the catheter families. |
P030036/S077 3/2/15 |
SelectSecure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P030053/S024 3/17/15 |
Mentor MEMORYGEL Silicone Gel-Filled Breast Implants | Mentor Worldwide LLC 201 Mentor Drive Santa Barbara, CA 93111 |
Change to automate the Gel Mix material sampling process to be used in the production of MemoryShape, and MemoryGel Silicone Gel-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
P040020/S056 3/19/15 |
AcrySof® ReSTOR® Intraocular | Alcon Research, Ltd. Fort Worth, TX 76134 |
Two alternate polypropylene resins, Basell PD702 and Total M3766. |
P040027/S040 3/20/15 |
Gore VIATORR TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Use of an ePTFE bonding film made from an alternate resin and the use of FEP film from an alternate supplier. |
P040036/S049 3/19/15 |
ThermoCool SmartTouch Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Additional qualified supplier for extrusion and braiding processes. |
P040036/S050 3/23/15 |
EZ Steer ThermoCool NAV | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Adding a second supplier for the 1mm sensor component used in the catheter families. |
P040043/S072 3/31/15 |
GORE® TAG® Thoracic Endoprosthesis | W.L. Gore and Associates Flagstaff, AZ 860003 |
Use film materials manufactured by Gore’s approved supplier on an alternating manufacturing line for GORE TAG Endoprosthesis and the GORE EXCLUDER AAA Endoprosthesis. |
P050006/S046 3/19/15 |
Gore HELEX Septal Occluder | W.L. Gore & Flagstaff, AZ 86001 |
Modification to the PVA specification. |
P050047/S045 3/4/15 |
Juvederm Hyaluronate Gel Implants | Allergan Irvine, CA 92623 |
Scale-up of a gel compounding line in the Juvederm manufacturing process. |
P050047/S046 3/26/15 |
Juvederm XC Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Expansion of the Pringy II manufacturing facility and associated minor changes to the utilities distribution system at the facility, to accommodate the added manufacturing space. |
P060006/S065 3/6/15 |
Express SD Renal Premounted Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
Modify the toolpath and software associated with the stent cutting lasers. |
P060006/S066 3/17/15 |
Express SD Renal Premounted Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
Software updates to the Full Body Stretcher of balloon components during the manufacturing process. |
P060022/S021 3/20/15 |
Akreos Intraocular Lens (IOL) | Bausch & Lomb Incorporated Irvine, CA 92618 |
Automated secondary packaging system. |
P060027/S073 3/17/15 |
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL102), Intensia VR ICD, Intensia DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Addition of Automated Optical Inspection (AOI) in manufacturing assembly line for the devices. |
P060027/S074 3/13/15 |
Paradym CRT-D, Paradym RF CRT-D, Paradym RF CRT-D, Intensia |
Sorin CRM USA, Inc. Arvada, CO 80004 |
Use of additional electrical welding equipment in the manufacturing laboratory. |
P060027/S075 3/19/15 |
Paradym CRT-D, Paradym RF CRT-D, Intensia CRT-D |
Sorin CRM USA, Inc. Arvada, CO 80004 |
Add an alternate supplier for the glue used in the die attach process for the hybrids used in the devices. |
P060028/S006 3/5/15 |
Mentor MemoryShape Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to the assigned shelf life of the final gel mix, implementation of new equipment and a change to the gel mixture sampling procedure. |
P060028/S007 3/17/15 |
MEMORYSHAPE Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to automate the Gel Mix material sampling process to be used in the production of MemoryShape, and MemoryGel Silicone Gel-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
P060028/S008 3/19/15 |
MEMORYSHAPE Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Changes in the production of MemoryShape Breast Implants manufactured at Mentor’s Irving, Texas facility. The changes include expanding the gowning area, increasing the number of drying rods in the shell drying oven and updating the bowl fill procedure. |
P060037/S034 3/27/15 |
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee | Zimmer, Inc. Warsaw, IN 46581 |
Incorporating the change in the device. |
P060039/S066 3/2/15 |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P060040/S039 3/24/15 |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Alternate method for the molding process of the HeartMate II Percutaneous Cables. |
P070026/S028 3/20/15 |
Ceramax Ceramic Total Hip System | DePuy Orthopedics, Inc. Warsaw, IN 46581 |
Add 2D barcode laser etching manufacturing process. |
P080006/S076 3/2/15 |
Attain Ability Lead, Attain Quadripolar Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P080025/S086 3/6/15 |
InterStim Therapy System | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Automate inspection of final device sealed tray package. |
P080025/S087 3/26/15 |
Sacral Nerve Stimulation, Bowel Implantable Neurostimulator (INS) Interstim Family | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Manufacturing change affecting the component of an implantable neurostimulator (INS) used for the Medtronic Neuromodulation Sacral Nerve Stimulation (SNS) therapies. |
P080025/S088 3/27/15 |
InterStim Therapy System | Medtronic Inc. Neuromodulation Minneapolis, MN 55432 |
Transfer of incoming inspection activities for a number of components. |
P090003/S038 3/6/15 |
Express LD Iliac Premounted Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
Modify the toolpath and software associated with the stent cutting lasers. |
P090013/S174 3/4/15 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Add alternative ultraviolet (UV) irradiator equipment in the manufacturing process for the devices. |
P090013/S175 3/1/15 |
Revo MRI IPG | Medtronic Incorporated Mounds View, MN 55112 |
Update the final visual inspection criteria for the hybrids used in the devices. |
P090013/S177 3/2/15 |
CapSureFix MRI Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new shrink wrap machine to the final packaging line. |
P090013/S178 3/11/15 |
CapSure Fix MRI Lead | Medtronic, Inc. Mounds View, MN 55112 |
Updates to procedures for torque testing at final functional inspection. |
P090016/S014 3/25/15 |
Belotero Balance Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Changes to the incoming inspection procedure for the Belotero balance dermal filler. |
P100023/S114 3/17/15 |
ION™ (TAXUS™ Element™) Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
Software updates to the Full Body Stretcher of balloon components during the manufacturing process. |
P100026/S030 3/6/15 |
NeuroPace RNS System | NeuroPace, Incorporated Mountain View, CA 94043 |
Modify the manufacturing and inspection process for the Wand (W-2). |
P100027/S021 3/19/15 |
INFORM HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Change in the metric used to monitor the manufacturing process of the INFORM HER2 Dual ISH DNA Probe Cocktail. In addition, the metric change, an increase in the number of slides tested for final acceptance testing, as well as an expansion of that final acceptance testing to include gastric tissue, will be implemented. |
P100041/S066 3/20/15 |
Edwards SAPIEN Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Add a chamber to the ethylene oxide sterilization process at the Sterigenics facility (Salt Lake City, Utah). |
P100047/S056 3/25/15 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Add an alternate second tier supplier and add a velour length trimming process for the HeartWare Ventricular Assist System. |
P110001/S012 3/27/15 |
Rx Herculink Elite Renal Stent System | Abbott Vascular Santa Clara, CA 95054 |
Addition of receiving inspection capabilities at the Clonmel, Ireland manufacturing site and contract laboratories. |
P110010/S103 3/17/15 |
PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
Software updates to the Full Body Stretcher of balloon components during the manufacturing process. |
P110021/S053 3/20/15 |
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Add a chamber to the ethylene oxide sterilization process at the Sterigenics facility (Salt Lake City, Utah). |
P110028/S015 3/19/15 |
Absolute Pro Vascular Self-Expanding Stent System | Abbott Vascular Santa Clara, CA 95054 |
Alternate resins in the manufacturing of the handle assembly for the Absolute Pro Vascular Self-Expanding Stent System. |
P110033/S013 3/26/15 |
Juvederm Voluma XC | Allergan Goleta, CA 93117 |
Expansion of the Pringy II manufacturing facility and associated minor changes to the utilities distribution system at the facility, to accommodate the added manufacturing space. |
P110035/S030 3/6/15 |
Epic Vascular Self-expanding Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
Modify the toolpath and software associated with the stent cutting lasers. |
P110035/S031 3/27/15 |
Epic Vascular Self-Expanding Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
Reduction to the post-electropolishing in-process monitoring inspections of the Epic stent component. |
P120010/S063 3/23/15 |
MiniMed 530G System | Medtronic Inc. Northridge, CA 91325 |
Modification to the laser cutting parameters for the Potomac Laser System used during the Enlite sensor manufacturing process in order to qualify it for use with the 48-UP sensor configuration. The Enlite Sensor is a component of the MiniMed 530G System. |
P120016/S009 3/11/15 |
Vascade Vascular Closure System | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Manufacturing of the Membrane Precondition subassembly in a new manufacturing facility located in Guaymas, Sonora Mexico. |
P120016/S010 3/20/15 |
VASCADE Vascular Closure System | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Transfer of the Push Rod subassembly to a new manufacturing location. |
P120016/S011 3/26/15 |
VASCADE Closure System | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Transfer of the Sleeve with Grip subassembly to a new manufacturing location. |
P120016/S012 3/31/15 |
VASCADE™ Vascular Closure System | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Transfer of the Epoxy Braid to Shaft subassembly to a new manufacturing location. |
P120020/S007 3/6/15 |
Supera Peripheral Stent System | Abbott Vascular Inc. Santa Clara, CA 95054 |
Addition of an alternate site for stent processing. |
P130009/S029 3/20/15 |
Edwards SAPIEN XT Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Add a chamber to the ethylene oxide sterilization process at the Sterigenics facility (Salt Lake City, Utah). |
P130016/S011 3/13/15 |
Nucleus Hybrid L24 Implant | Cochlear Americas Centennial, CO 80111 |
Addition of the helium bombing, and removal of gross leak test for the Magnet Assembly. |
P130021/S011 3/31/15 |
Medtronic CoreValve System | Medtronic CoreValve LLC Santa Rosa, CA 95403 |
Expand the capacity of the clean rooms used to manufacture the CoreValve Transcatheter Aortic Valve at the Medtronic Mexico facility. |
P130030/S010 3/17/15 |
Rebel™ Platinum Chromium Coronary Stent System | Boston Scientific Corp. Maple Grove, MN 55311 |
Software updates to the Full Body Stretcher of balloon components during the manufacturing process. |