Summary of PMA Originals & Supplements Approved
- Originals: 2
- Supplements: 60
Summary of PMA Originals Under Review
- Total Under Review: 63
- Total Active: 32
- Total On Hold: 31
Summary of PMA Supplements Under Review
- Total Under Review: 495
- Total Active: 359
- Total On Hold: 136
Summary of All PMA Submissions
- Originals: 10
- Supplements: 85
Summary of PMA Supplement PMA Approval/Denial Decision Times
- Number of Approvals: 62
- Number of Denials: 0
- Average Days Fr Receipt to Decision (Total Time): 155.7 Days
- FDA Time: 122.5 Days
- MFR Time: 33.2 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P140010 12/30/14 |
IN.PACT™ Admiral™ Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Medtronic, Inc. Santa Rosa, CA 95403 |
Approval for the IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter. This device is indicated for percutaneous transluminal angioplasty, after predilatation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm. |
P140020 12/19/14 |
BRACAnalysis CDx™ | Myriad Genetic Laboratories, Inc. Salt Lake City, UT 84108 |
Approval for the BRACAnalysis CDx. This device is indicated as follows: BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparz (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located Salt Lake City, Utah. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P830055/S150 12/8/14 180-Day |
LCS® Total Knee System | DePuy Orthopaedics, Incorporated Warsaw, IN 46582 |
Approval for the addition of Tru-Match Pin Guides as compatible Components with the DePuy LCS® Total Knee System and the addition of Medical Modeling Incorporated as a manufacturing site for these components. |
P830055/S152 12/31/14 Real-Time |
LCS® Total Knee System | DePuy Orthopaedics, Incorporated Warsaw, IN 46582 |
Approval for the addition of a segmentation software package for use in the design of TruMatch® Resection Guides and Pin Guides. |
P840001/S273 12/5/14 180-Day |
ITREL 4 RESTORE SENSORY SURE SCAN MRT NEURO STIMULATION SYSTEMS | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for the changes to the Patient Programmer and Patient Recharge Kit used for Medtronic Spinal Cord Stimulation and Deep Brain Stimulation. |
P850048/S038 12/23/14 135-Day |
Access Hybritech PSA Assay | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for a change to the current reagent Real-Time stability test method for Access Reagent Packs, Calibrators and Samples Diluents to enhance the safety and reliability of the devices per 21 CFR 814.39(d)(2). |
P880086/S248 12/22/14 Real-Time |
Endurity Pacemakers | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the addition of non-functional jumper connections for the hybrid assemblies utilized in the devices. |
P880086/S249 12/11/14 Real-Time |
Assurity, Assurity+, Endurity, Accent Family of Pacemakers | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Model EX2000 v8.0 Software for the Models EX1100 and EX1150 Merlin@home transmitters used with the devices. |
P900056/S139 12/8/14 180-Day |
Rotablator Rotational Angioplasty System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica. |
P910023/S346 12/11/14 Real-Time |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs Model EX2000 v8.0 Software for the Models EX1100 and EX1150 Merlin@home Transmitters |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Model EX2000 v8.0 Software for the Models EX1100 and EX1150 Merlin@home transmitters used with the devices. |
P920047/S072 12/19/14 180-Day |
Maestro 4000™ Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for design changes, labeling changes, and a manufacturing site change of the Sterllartech Research Corporation from Sunnyvale, CA to Milpitas, CA for the Maestro 4000™ Cardiac Ablation System. |
P920047/S073 12/8/14 180-Day |
Blazer II Cardiac Ablation Catheter | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica. |
P930027/S016 12/3/14 135-Day |
IMMULITE®/ IMMULITE® 1000, IMMULITE® 2000 PSA |
Siemens Healthcare Diagnostics Products Ltd. Gwynedd, UK LL55 4EL |
Approval for an additional assessment method by utilizing a panel of 10 normal male sera and a release panel of patient pools to maintain the performance of the device aligned to the WHO standard 96/670. |
P950029/S099 12/15/14 Real-Time |
Reply/Esprit SR/DR Pacemakers | Sorin Group Arvada, CO 80004 |
Approval for a modified desiccant and new battery insulator to be used in the final finished devices. |
P950029/S101 12/23/14 Special |
Reply and Esprit Family of Pacemakers | Sorin CRM Arvada, CO 80004 |
Approval for optimization of the gluing process for the silicone caps. |
P960009/S197 12/5/14 180-Day |
ACTIVA DEEP BRAIN STIMULATION SYSTEM | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for the changes to the Patient Programmer and Patient Recharge Kit used for Medtronic Spinal Cord Stimulation and Deep Brain Stimulation. |
N970012/S099 12/8/14 135-Day |
AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for use of different equipment by a vendor to quantify the level of antimicrobial active ingredient. |
P970038/S027 12/23/14 135-Day |
Access Hybritech free PSA Reagent /Calibrator Kit | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for a change to the current reagent Real-Time stability test method for Access Reagent Packs, Calibrators and Samples Diluents to enhance the safety and reliability of the devices per 21 CFR 814.39(d)(2). |
P980003/S052 12/19/14 180-Day |
Maestro 4000™ Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for design changes, labeling changes, and a manufacturing site change of the Sterllartech Research Corporation from Sunnyvale, CA to Milpitas, CA forthe Maestro 4000™ Cardiac Ablation System. |
P980003/S053 12/8/14 180-Day |
Chilli II Cooled Ablation Catheter System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica. |
P980040/S049 12/17/14 180-Day |
TECNIS® Multifocal 1-Piece Intraocular Lens | Abbott Medical Optics Inc. Santa Ana, CA 92705 |
Approval for the TECNIS® Multifocal 1-Piece Intraocular Lens, Models ZKB00 and ZLB00. This device is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag. |
P980041/S028 12/23/14 135-Day |
Access AFP Immunoassay System | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for a change to the current reagent Real-Time stability test method for Access Reagent Packs, Calibrators and Samples Diluents to enhance the safety and reliability of the devices per 21 CFR 814.39(d)(2). |
P000025/S078 12/8/14 |
MED-EL COMBI 40+ Cochlear Implant System | MED-EL Corporation Durham, NC 27713 |
Approval for the SONNET audio processor, MAESTRO 6.0 software, and RONDO WaterWear accessory. |
P000053/S051 12/8/14 135-Day |
AMS 800 Urinary Control System with InhibiZone Treatment | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for use of different equipment by a vendor to quantify the level of antimicrobial active ingredient. |
P010033/S025 12/5/14 180-Day |
QuantiFERON®-TB Gold | QIAGEN Incorporated Gaithersburg, MD 20878 |
Approval for a manufacturing site located at QIAGEN in Germantown, Maryland. |
P020009/S125 12/8/14 180-Day |
Express 2 Monorail and Over-the-Wire Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica. |
P020012/S009 12/23/14 Panel-Track |
Bellafill | Suneva Medical, Inc. Santa Barbara, CA 93111 |
Approval for the Bellafill. This device is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years. |
P020014/S042 12/11/14 180-Day |
Essure System for Permanent Birth Control | Bayer Healthcare, LLC Milpitas, CA 95035 |
Approval of the post-approval study protocol. |
P020025/S060 12/19/14 180-Day |
Maestro 4000™ Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for design changes, labeling changes, and a manufacturing site change of the Sterllartech Research Corporation from Sunnyvale, California to Milpitas, California for the Maestro 400 Cardiac Ablation System. |
P020025/S061 12/8/14 180-Day |
Blazer II XP Cardiac Ablation Catheter and Cable | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica. |
P020050/S017 12/17/14 180-Day |
WaveLight® EX500 Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for an alternate supplier for a camera sensor component of the Eyetracker camera for the WaveLight® EX500 Laser System. |
P030008/S015 12/17/14 180-Day |
WaveLight® EX500 Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for an alternate supplier for a camera sensor component of the Eyetracker camera for the WaveLight® EX500 Laser System. |
P030016/S027 12/22/14 180-Day |
Visian Implantable Collamer Lens | Staar Surgical Company Monrovia, CA 91016 |
Approval to add new calculator software to the Visian Implantable Collamer Lens (ICL). |
P030017/S202 12/19/14 180-Day |
Precision® and Precision Spectra™ Spinal Cord Stimulation (SCS) Systems | Boston Scientific Neuromodulation Valencia, CA 91355 |
Approval for the Precision M8 Adapter that will be used to connect the Precision Implantable Pulse Generator (IPG) or the Precision Spectra IPG to the following Medtronic (MDT) SCS Leads: Specify 2×8 Model 39286, Specify 5-6-5 Model 39565, lx8 Compact Model 3778, lx8 Standard Model 3777, lx8 Sub-Compact Model 3776, Test: lx8, Compact Model 3874, Test: lx8 Standard Model 3873, Test: lx8 Sub-Compact Model 3875, Model 37081 Extension, Model 37083 Extension, Model 37082 Extension, Vectris™ SureScan® MRI lx8 Subcompact, Model 977A160, 977A175, 977A190, and Vectris™ SureScan® MRI lx8 Compact, Model 977A260, 977A275, 977A290. |
P030035/S126 12/22/14 Real-Time |
Allure CRT-P and Allure Quadra CRT-P |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for the addition of non-functional jumper connections for the hybrid assemblies utilized in the devices. |
P030035/S127 12/11/14 Real-Time |
Anthem, Allure/RF, Allure Quadra/RF Family of CRT-Ps | St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Model EX2000 v8.0 Software for the Models EX1100 and EX1150 Merlin@home transmitters used with the devices. |
P030054/S276 12/11/14 Real-Time |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ HF, Atlas+HF/II HH/II+ HF Family of CRT-Ds |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Model EX2000 v8.0 Software for the Models EX1100 and EX1150 Merlin@home transmitters used with the devices. |
P040001/S021 12/12/14 180-Day |
X-STOP® Interspinous Spacer System | Medtronic Sofamor Danek USA, Incorporated Memphis, TN 38132 |
Approval for an update to the X STOP® Interspinous Spacer System labeling to reflect the results from the Long Term Outcomes Study (LTOS) that was conducted as a postapproval study requirement. |
P040002/S047 12/31/14 180-Day |
AFX Endovascular Abdominal Aortic Aneurysm (AAA) Stent System | Endologix, Inc. Irvine, CA 92618 |
Approval for a manufacturing site located in Irvine, California. |
P040016/S131 12/8/14 180-Day |
VeriFLEX (Liberte) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica. |
P040024/S076 12/8/14 135-Day |
Restylane, Restylane-L Perlane, and Perlane-L Injectable Gels | Galderma Laboratories, L.P. Fort Worth, TX 76177 |
Approval for the proposed introduction of an alternate bulk manufacturing room in the manufacturing process used in Factory 2 (F2) at the Q-Med facility in Uppsala, Sweden. |
P040034/S024 12/11/14 180-Day |
DuraSeal Dural Sealant System | Integra LifeSciences Corporation Burlington, MA 01803 |
Approval for a change to the Directions for Use (DFU) to expand the patient population to > 13 years of age. |
P050044/S029 12/12/14 135-Day |
Vitagel RT3 Surgical Hemostat | Stryker Orthobiologics Malvern, PA 19355 |
Approval for the relocation of certain manufacturing equipment used for assembly and packaging of Vitagel RT3 Surgical Hemostat from one room to another room within the firm’s Malvern, Pennsylvania facility. |
P050047/S043 12/5/14 Special |
JUVÉDERM Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Approval for strengthening the current warning and discussing the potential adverse reaction(s) associated with intravascular injection. |
P060006/S062 12/8/14 180-Day |
Express SD Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica. |
P070001/S012 12/22/14 135Day |
ProDisc-C Total Disc | DePuy Synthes Spine Raynham, MA 02767 |
Approval for a change in manufacturing of the packaging. |
P080006/S073 12/10/14 180-Day |
Attain PerformaTM Left Ventricular Leads | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Attain PerformaTM Left Ventricular Leads (Models 4398 and 4598), indicated for chronic pacing in the left ventricle via the cardiac vein, when used with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. |
P080012/S022 12/18/14 180-Day |
Prometra Programmable Infusion Pump System | Flowonix Medical, Inc. Mount Olive, NJ 07828 |
Approval for implementing a design change to incorporate a flow actuated safety valve (FAV) to the Prometra Pump. |
P080030/S012 12/16/14 180-Day |
Glaukos® Corporation iStent® Trabecular Micro-Bypass Stent System, Models GTS100R, GTS100L (Stent Systems) and GTS100i (Stand-Alone Inserter) |
Glaukos Corporation Laguna Hills, CA 92653 |
Approval for the modifications to the Model GTS100i inserter and stent, which comprise the iStent Trabecular Micro-Bypass Stent System. The modifications include the following: 1) Changes to the inserter to include: a) A larger Sleeve diameter for increased rigidity of the Slide Assembly; b) An increase in the internal spring force; c) A change to the geometry and extension of the grasping tines on the end of the Slotted Tube; d) A re-design of the Release Button Rocker mechanism; and e) Color changes to two outer inserter components (rear housing and trigger button). 2) Changes to the stent to include: a) An increase in the wall thickness of the snorkel by tightening the dimensional tolerance from a range 0.155 to 0.200 mm to a range of 0.170 to 0.200 mm; and b) Removal of the stenting height parameter from the finished device drawings 10-0018 and 10-0019 as a critical dimension. 3) Changes to the stent system to include: a) A change from sterilization following primary packaging to sterilization following final packaging; and b) Elimination of the in-process grip force testing step. |
P090012/S005 12/19/14 135-Day |
MelaFind | MELA Sciences, Incorporated Irvington, NY 10533 |
Transfer responsibility to perform integration of system (Cart assembly and hand-held imager) from MELA Sciences to a contract manufacturer |
P090026/S012 12/23/14 135-Day |
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for a change to the current reagent Real-Time stability test method for Access Reagent Packs, Calibrators and Samples Diluents to enhance the safety and reliability of the devices per 21 CFR 814.39(d)(2). |
P100003/S005 12/18/14 180-Day |
SECURE®-C Cervical Artificial Disc | Globus Medical, Incorporated Audubon, PA 19403 |
Approval for additional device sizes. |
P100012/S006 12/19/14 180-Day |
PCM® Cervical Disc System | NuVasive, Incorporated San Diego, CA 92121 |
Approval for a locking plate design modification, additional device sizes and Magnetic Resonance (MR) conditional labeling. |
P100021/S044 12/19/14 Special |
Endurant, Endurant II, Endurant IIs, and Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System | Medtronic Inc. Santa Rosa, CA 95403 |
Approval for the addition of a manufacturing aid during the hydrophilic coating process. |
P100023/S102 12/8/14 180-Day |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica. |
P100023/S110 12/18/14 180-Day |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval of the post-approval study protocol. |
P110010/S089 12/8/14 180-Day |
PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica. |
P110012/S007 12/10/14 Real-Time |
Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Inc. Des Plaines, IL 60016 |
Approval for modifications to the ProbeChk ALK Positive and Negative Control Slide labeling, and expansion of the assay guard band parameters. |
P110013/S046 12/18/14 Real-Time |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a change in the shelf life for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System from 18 months to 24 months. |
P120006/S013 12/18/14 135-Day |
Ovation and Ovation Prime Abdominal Stent Graft System | TriVascular, Inc. Santa Rosa, CA 95403 |
Approval to change the manufacturing process for the ipsilateral tab on the aortic body stent graft from manual to automated. |
P120014/S002 12/22/14 135-Day |
THxID™ BRAF Kit | BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the following seven changes: Cleaning of dripping and spheres filling equipment, transfer of quality control activities into another room, raw material changes for bottles and caps for THxID-BRAF PUR, modification of a functional quality control (QC) test for the THxIDTM-BRAF PUR kit, transfer of buffer manufacturing (for the BRAF purification kit) into a new building at Qiagen, changes in DNase reference (AM2224) used in the determination of DNase activity in water and reagents, and shelf life extension for RNA transcripts and plasmids. |
P130021/S008 12/10/14 Real-Time |
Medtronic CoreValve® System | Medtronic CoreValve LLC Santa Rosa, CA 95403 |
Approval for the introduction of a revised cursor spring for the AccuTrak Delivery Catheter System (DCS). |
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/S045 12/2/14 |
Hancock Modified Orifice Valved Conduit | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
P810002/S091 12/15/14 |
Regent Mechanical Heart Valve, Standard and Masters Mechanical Heart Valve |
St. Jude Medical, Inc. St Paul, MN 55117 |
Implementation of new proof tester units. |
P810002/S092 12/18/14 |
St. Jude Medical Mechanical Heart Valves, St. Jude Medical Masters Series Mechanical Heart Valves, St. Jude Medical Regent Heart Valves |
St. Jude Medical, Inc. St Paul, MN 55117 |
Addition of a new grinding machine for removal of excess pyrolytic coating. |
P810006/S058 12/18/14 |
CollaStat Absorbable Collagen, Hemostatic Sponge CollaStat Absorbable Collagen, Hemostatic Agent-Microfibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Upgrade to the MicroFib Grinder blade for the devices. |
P830055/S153 12/18/14 |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Implement additional device identification measures. |
P840001/S286 12/22/14 |
SCS Extensions, SCS Leads 1×8 Family, and SCS Leads Pisces Family, SCS Leads Specify Family |
Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Change the sampling strategy for the special manufacturing process monitoring. |
P840064/S058 12/12/14 |
DUOVISC® Ophthalmic Viscosurgical Device, DISCOVISC® Ophthalmic Viscosurgical Device | Alcon Research, Ltd. Fort Worth, TX 76134 |
Addition of an alternate supplier for the 1 ml silicone barrels. |
P850010/S057 12/18/14 |
HeliStat, Helitene Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Upgrade to the MicroFib Grinder blade for the devices. |
P870076/S015 12/4/14 |
Disposable Falope-Ring Band Applicator Kits | Gyrus ACMI, Inc. Southborough, MA 01772 |
Adjustment of the sealing parameters and the repeat of a peel strength test and visual check. |
P870078/S029 12/2/14 |
Hancock Low Porosity Valved Conduit | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
P890003/S325 12/12/14 |
Prodigy IPG | Medtronic CRDM Mounds View, MN 55112 |
Modifications to the in-process battery inspection requirements for the batteries used in the devices. |
P890047/S045 12/12/14 |
PROVISC® Ophthalmic Viscosurgical Device | Alcon Research, Ltd. Fort Worth, TX 76134 |
Addition of an alternate supplier for the 1 ml silicone barrels. |
P900009/S038 12/8/14 |
EXOGEN Ultrasound Bone Healing System | Bioventus LLC. Durham, NC 27703 |
Addition of a new servicing process. |
P900056/S143 12/12/14 |
Rotablator® Rotational Angioplasty System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an alternate test method for the non-destructive pull tensile test for the RotaWire component. |
P910001/S074 12/16/14 |
ELCA Coronary Atherectomy Catheters | Spectranetics Corp. Colorado Springs, CO 80921 |
Remove repeated steps from the manufacturing process. |
P910007/S046 12/11/14 |
ARCHITECT Total PSA | Abbott Laboratories Abbott Park, IL 60064 |
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices. |
P910007/S047 12/8/14 |
ARCHITECT Total PSA | Abbott Laboratories Abbott Park, IL 60064 |
Replace an existing supplier with a new supplier for bovine serum albumin (BSA). |
P910023/S349 12/15/14 |
Current Accel DR, Current Accel VR, Current+ VR, Current+ DR |
St. Jude Medical Sylmar, CA 91342 |
Alternate component attach material for the GMR component on hybrid assemblies for the devices. |
P920047/S075 12/17/14 |
Blazer II, Blazer II HTD Temperature Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Transfer of a device component production site. |
P950005/S055 12/8/14 |
Celsius Flutters, Celsius, Celsius RMT, EZ Steer 4mm Non-Nav, EZ Steer DS |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Additional supplier for extrusion and braiding processes. |
P950029/S100 12/16/14 |
Reply SR, Reply DR, Esprit SR, Esprit DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Addition of a C-Mode Scanning Acoustic Microscopy system in the manufacturing assembly line. |
P950037/S145 12/3/14 |
DEXTRUS, SETROX S, TILDA, SAFIO S LEADS | Biotronik, Inc. Lake Oswega, OR 97035 |
Alternative assembly process for pacemaker leads. |
P950039/S032 12/10/14 |
ThinPrep Processor 2000/3000 | Hologic, Inc Marlborough, MA 01752 |
Minor modification of the Liquid Crystal Display (LCD) circuit board used in the ThinPrep 2000 Processor display. |
P960004/S067 12/11/14 |
FINELINE II Sterox Lead | Boston Scientific Corporation St. Paul, MN 55112 |
Modify the Hipot test specifications conducted during the Brady leads manufacturing. |
P960009/S212 12/22/14 |
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Change the sampling strategy for the special manufacturing process monitoring. |
P960040/S338 12/19/14 |
ORIGEN, DYNAGEN, INOGEN, INCEPTA, ENERGEN, PUNCTUA Family of ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Changes to the crystal oscillator component manufacturing process at the current supplier. |
P960040/S339 12/12/14 |
ORIGEN™ EL ICD, ORIGEN™ MINI ICD, DYNAGEN™ EL ICD, DYNAGEN™ MINI ICD, INOGEN™ EL ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Modify the crystal oscillator manufacturing process at an existing supplier for the devices. |
P960058/S113 12/12/14 |
HiResolution Bionic Ear System | Advanced Bionics, LLC Valencia, CA 91355 |
Relocate the ICS hybrid serialization process from the hybrid manufacturer to in-house hybrid serialization process at Advanced Bionics. |
P970003/S175 12/17/14 |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Implementation of a new routing fixture. |
P970004/S186 12/22/14 |
INTERSTIM THERAPY SYSTEM | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Change the sampling strategy for the special manufacturing process monitoring. |
P970021/S042 12/4/14 |
GYNECARE THERMACHOICE III Uterine Balloon Therapy System | ETHICON, Inc. Somerville, NJ 08876 |
Manufacturing changes to the GYNECARE THERMACHOICE II Controller to meet and comply with the European Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU by replacing non-RoHS compliant components with functionally equivalent RoHS compliant components. |
P970031/S049 12/2/14 |
Freestyle Aortic Root Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
P970051/S124 12/12/14 |
Cochlear Nucleus CI512 Implant System | Cochlear Americas Centennial, CO 80111 |
Update a misalignment between inspections conducted post-top shell fill molding and the silicone finishing inspection at subsequent operations. |
P970051/S125 12/12/14 |
Cochlear Nucleus CI512 Implant System | Cochlear Americas Centennial, CO 80111 |
Update the electronic assembly inspection standard and align the electronic assembly inspection standard with the current inspection standards for the nucleus cochlear implant system. |
P980003/S055 12/17/14 |
Chilli II Cooled Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Transfer of a device component production site. |
P980007/S037 12/11/14 |
ARCHITECT Free PSA | Abbott Laboratories Abbott Park, IL 60064 |
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices. |
P980007/S038 12/8/14 |
ARCHITECT Free PSA | Abbott Laboratories Abbott Park, IL 60064 |
Replace an existing supplier with a new supplier for bovine serum albumin (BSA). |
P980016/S509 12/4/14 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic CRDM Mounds View, MN 55112 |
Additional inspection step in the capacitor assembly epoxy process for the devices. |
P980016/S510 12/12/14 |
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD | Medtronic CRDM Mounds View, MN 55112 |
Update to the Pre-Pulse Open Circuit Test limits. |
P980016/S511 12/19/14 |
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 |
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the devices. |
P980016/S512 12/19/14 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD | Medtronic CRDM Mounds View, MN 55112 |
New rework manufacturing process for the bonded anode subassembly used in the capacitors for the devices. |
P980022/S164 12/4/14 |
Paradigm REAL‐ Time System, Paradigm REAL‐ Time Revel System, Guardian Real‐Time System, MiniLink REAL‐Time System, iPro2 Professional Continuous Glucose Monitoring System |
Medtronic, Inc. Northridge, CA 91325 |
Implementation of five additional pieces of equipment at a contract manufacturer to support the manufacture of the lithium polymer batteries for the MiniLink REAL-Time Transmitter model number MMT-7703 and the iPro2 Digital Recorder model number MMT-7741. The MiniLink Transmitter is a component of the Paradigm REAL‐ Time System, Paradigm REAL‐ Time Revel System, Guardian Real‐Time System, MiniLink REAL‐Time System, as well as the MiniMed 530G System. The iPro2 Recorder is a component of the iPro2 Professional Continuous Glucose Monitoring System. |
P980022/S170 12/3/14 |
Paradigm REAL-Time System Paradigm REAL-Time Revel System |
Medtronic MiniMed Inc. Northridge, CA 91325 |
Change to a rejection criterion in the harvest of used motors during the manufacturing of refurbished pumps. The motor is a part of the insulin pump in the Paradigm REAL-Time System (MMT-522, MMT-722, MMT-522K, MMT-722K), the Paradigm REALTime Revel System (MMT-523, MMT-723, MMT-523K, MMT-723K), and the MiniMed 530G System (MMT-551, MMT-751). |
P980022/S171 12/3/14 |
Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time CGM System, MiniLink REAL-Time System, iPro2 Professional CGM System |
Medtronic MiniMed Inc. Northridge, CA 91325 |
Change in the curing time during the manufacturing process for the Sen- Serter, which is a component of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time CGM System, MiniLink REAL-Time System, and iPro2 Professional CGM System. |
P980022/S172 12/5/14 |
Paradigm Real-Time System, Paradigm Real-Time Revel System, Guardian REAL-Time System |
Medtronic MiniMed Inc. Northridge, CA 91325 |
Additional manufacturing testing to be performed on a previously approved component used in the manufacture of the Paradigm REAL-Time Insulin Pumps (MMT-522, MMT-522K, MMT-722, MMT-722K) and the Paradigm REAL-Time Revel Insulin Pumps (MMT-523, MMT-523K, MMT-723, MMT-723K) that are part of the Paradigm Real-Time System and the Paradigm Real-Time Revel System respectively. This component is also used in the Guardian REAL-Time Monitor (CSS7100, CS7100K) that is part of the Guardian REALTime System. |
P980022/S173 12/19/14 |
Paradigm Real-Time System, Paradigm Real-Time Revel System |
Medtronic, Inc. Northridge, CA 91325 |
Reprogramming of new PC boards/ stacks for the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K, MMT-723, MMT-723K), and MiniMed 530G Insulin Pump (Models: MMT-551, MMT-751) in Medtronic Puerto Rico Operations Co. (MPROC). The Paradigm REAL-Time Insulin Pump, Paradigm REAL-Time Revel Insulin Pump, and MiniMed 530G Insulin Pump are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, and MiniMed 530G System, respectively. |
P980035/S401 12/12/14 |
Adapta, Versa, Sensia IPGs, Advisa DR IPG, Relia IPGs, | Medtronic CRDM Mounds View, MN 55112 |
Modifications to the in-process battery inspection requirements for the batteries used in the devices. |
P980035/S402 12/23/14 |
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, and Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 |
New final functional tester for final device assembly manufacturing facilities. |
P980035/S403 12/19/14 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG | Medtronic CRDM Mounds View, MN 55112 |
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the devices. |
P980040/S054 12/17/14 |
TECNIS® 1-Piece IOL with the TECNIS iTec Preloaded Delivery System |
Abbott Medical Optics, Inc. Santa Anna, CA 92705 |
Alternate molding supplier for the lower body and protector cap components of the TECNIS iTec Preload Delivery System. |
P980040/S055 12/31/14 |
TECNIS® 1-Piece IOL, TECNIS® Multifocal 1-Piece IOL, TECNIS® Toric 1-Piece IOL, SENSAR® 1-Piece IOL and TECNIS® OptiBlue® 1-Piece IOL |
Abbott Medical Optics, Inc. Santa Anna, CA 92705 |
Alternate supplier for an intraocular packaging component. |
P980041/S031 12/8/14 |
Access AFP Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Modification to the Quality Control standard operations procedures for AFP prefill and postfill reagent pack. |
P980043/S051 12/2/14 |
Hancock II Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
P980044/S020 12/17/14 |
SUPARTZ | Seikagaku Corporation Tokyo, Japan 100-0005 |
Replace a previous autoclave with a new autoclave. |
P980044/S021 12/17/14 |
SUPARTZ | Seikagaku Corporation Tokyo, Japan 100-0005 |
SPECTROPHOTOMETER SYSTEM T A007 FOR BACTERIAL ENDOTOXIN TESTING FOR BOTH IN PROCESS SAMPLES AND SUPARTZ |
P980044/S022 12/17/14 |
SUPARTZ | Seikagaku Corporation Tokyo, Japan 100-0005 |
NEW TOTAL ORGANIC CARBON METER FOR SUPARTZ FINISHED DEVICE AT SKK- TAKAHAGI FACILITY. |
P980044/S023 12/17/14 |
SUPARTZ | Seikagaku Corporation Tokyo, Japan 100-0005 |
TWO NEW AUTOCLAVES FOR MICROBIOLOGICAL TESTING IN THE SSK-TAKAHAGI PLANT |
P980049/S104 12/16/14 |
Paradym VR 8750, Paradym DR 8750, Paradym RF VR 9750, Paradym RF DR 9750, Paradym RF VR 9750, Paradum RF DR 9750, Intensia VR ICD, Intensia DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Addition of a C-Mode Scanning Acoustic Microscopy system in the manufacturing assembly line. |
P990012/S022 12/22/14 |
Elecsys® HBsAg Immunoassay, Elecsys® HBsAg PreciControl, and Elecsys® HBsAg Confirmatory Test | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Relocation of the final kit assembly and labeling operations to a new building within the same facility. |
P990025/S043 12/8/14 |
NAVISTAR ELECTROPHYSIOLOGY CATHETER | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Additional supplier for extrusion and braiding processes. |
P990064/S060 12/2/14 |
Mosaic Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
P990071/S030 12/12/14 |
SmartAblate System | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change to the assembler of the Printed Circuit Board Modules (PCB Modules) that are used in the SmartAblate System. |
P990075/S030 12/15/14 |
Mentor SPECTRUM and Saline-Filled Breast Implants | Mentor Worldwide LLC Somerville, NJ 08876 |
Change to automate the existing silicone elastomer sheet cutter used to cut part components for Mentor Saline-Filled and SPECTRUM Breast Implants, Mentor MemoryGel Silicone Gel-Filled Breast Implants and Mentor MemoryShape Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
P990075/S031 12/16/14 |
Mentor SPECTRUM and Saline-Filled Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to automate the manual Secondary Packaging process to be used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
P990081/S031 12/4/14 |
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Change in the manufacturing parameters for the Ventana reagent dispenser vent seal. |
P000012/S050 12/4/14 |
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/ COBAS® AMPLICOR® HCV Test version 2.0 |
Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Discontinuation of an in-process QC test. |
P000014/S028 12/11/14 |
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, VITROS Immunodiagnostic Products Anti-HBs Calibrators | Ortho Clinical Diagnostics Rochester, NY 14626 |
Removal of an upper test limit specification of a curve-shape parameter in an in-process quality control functionality test. |
P000027/S020 12/22/14 |
Elecsys® Free PSA Immunoassay, Elecsys® Free PSA CalSet, and Elecsys® Free PSA CalCheck | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Relocation of the final kit assembly and labeling operations to a new building within the same facility. |
P000032/S042 12/18/14 |
Her Option Cryoablation Therapy System | Cooper Surgical, Inc. Trumbull, CT 06611 |
Change to the quality control high potential electrical safety analyzer from one device to another. |
P010012/S378 12/12/14 |
DYNAGEN™ CRT-D, DYNAGEN™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, ORIGEN™ CRT-D, ORIGEN™ X4 CRT-D, INCEPTA™ ICD, ENERGEN™ ICD, PUNCTUA™ ICD |
Boston Scientific Corporation St. Paul, MN 55112 |
Modify the crystal oscillator manufacturing process at an existing supplier for the devices. |
P010012/S379 12/19/14 |
ORIGEN, DYNAGEN, INOGEN, Family of CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Changes to the crystal oscillator component manufacturing process at the current supplier. |
P010015/S254 12/19/14 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P | Medtronic CRDM Mounds View, MN 55112 |
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the devices. |
P010031/S473 12/4/14 |
Brava CRT-D, 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 CRDM Mounds View, MN 55112 |
Additional inspection step in the capacitor assembly epoxy process for the devices. |
P010031/S474 12/12/14 |
Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D |
Medtronic CRDM Mounds View, MN 55112 |
Update to the Pre-Pulse Open Circuit Test limits. |
P010031/S475 12/19/14 |
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 CRDM Mounds View, MN 55112 |
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the devices. |
P010031/S476 12/19/14 |
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D | Medtronic CRDM Mounds View, MN 55112 |
New rework manufacturing process for the bonded anode subassembly used in the capacitors for the devices. |
P010032/S088 12/19/14 |
Eon Implantable Pulse Generator, EonC Implantable Pulse Generator, Eon Mini Implantable Pulse Generator, Protégé Implantable Pulse Generator, Protégé MRI Implantable Pulse Generator |
St. Jude Medical Plano, TX 75024 |
Replace the AK-225 solvent used during the manufacturing process of the Implantable Pulse Generators. |
P010032/S089 12/18/14 |
Tripole 16 Leads and Tripole 16C Lead, Exclaim Leads, Lamitrode 4 Lead, Lamitrode 44 Lead, Lamitrode 44C Lead, Lamitrode 88 Lead, Lamitrode S-4 Leads, Lamitrode S-8 Leads, Penta Leads, Octrode Leads, Quattrode Leads, A127 Lead Extension, Dual 4 Extension, Single 8 Extension, IS-1 Pocket Adapters, 8-Channel Adapters, M |
St. Jude Medical Plano, TX 75024 |
Implement manufacturing process changes. |
P010033/S026 12/10/14 |
QuantiFERON®-TB Gold | QIAGEN, Incorporated Gaithersburg, MD 20878 |
Change to the manufacturing process for bulk peptide solutions. |
P010054/S024 12/22/14 |
Elecsys® Anti-HBs Immunoassay, Elecsys® PreciControl Anti-HBs and Elecsys® Anti-HBs CalCheck | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Relocation of the final kit assembly and labeling operations to a new building within the same facility. |
P010068/S044 12/8/14 |
NaviStar DS, Celsius DS, EZ Steer Nav DS, NaviStar RMT DS, Celsius Flutters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Additional supplier for extrusion and braiding processes. |
P020016/S007 12/9/14 |
Total Temporomandibular Joint Replacement System | Biomet Microfixation Jacksonville, FL 32218 |
Eliminate a step within the manufacturing process to remove the itch on the Titanium Mandibular, Cobalt Chrome mandibular and Fossa components |
P020025/S065 12/17/14 |
Blazer II XP Temperature Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Transfer of a device component production site. |
P020055/S016 12/4/14 |
Pathway Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Change in the manufacturing parameters for the Ventana reagent dispenser vent seal. |
P030002/S032 12/4/14 |
Crystalens, Trulign Toric Intraocular Lens | Valeant Pharmaceuticals International, Incorporated Irvine, CA 92688 |
Alternate cosmetic inspection process. |
P030006/S027 12/16/14 |
Prolieve Thermodilatation System | Medifocus Incorporated Columbia, MD 21046 |
Change to replace the manual process of sanding the surface plates of the heat exchanger. |
P030031/S064 12/8/14 |
NaviStar ThermoCool, Celsius ThermoCool, NaviStar RMT, ThermoCool, EZ Steer ThermoCool, Celsius RMT ThermoCool, ThermoCool SF, ThermoCool ST | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Additional supplier for extrusion and braiding processes. |
P030053/S021 12/15/14 |
Mentor MEMORYGEL Silicone Gel-Filled Breast Implants | Mentor Worldwide LLC Somerville, NJ 08876 |
Change to automate the existing silicone elastomer sheet cutter used to cut part components for Mentor Saline-Filled and SPECTRUM Breast Implants, Mentor MemoryGel Silicone Gel-Filled Breast Implants and Mentor MemoryShape Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
P030053/S022 12/16/14 |
Mentor MEMORYGEL Silicone Gel-Filled Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to automate the manual Secondary Packaging process to be used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
P030054/S279 12/15/14 |
Promote Accel, Promote+ | St. Jude Medical Sylmar, CA 91342 |
Alternate component attach material for the GMR component on hybrid assemblies for the devices. |
P040043/S070 12/17/14 |
Gore TAG Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change to an in-process inspection step of the GORE TAG Thoracic Endoprosthesis manufacturing process. |
P050042/S031 12/11/14 |
ARCHITECT Anti-HCV | Abbott Laboratories Abbott Park, IL 60064 |
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices. |
P050051/S028 12/11/14 |
ARCHITECT AUSAB | Abbott Laboratories Abbott Park, IL 60064 |
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices. |
P050051/S029 12/30/14 |
ARCHITECT AUSAB | Abbott Laboratories, Diagnostics Division Abbott Park, IL 60064 |
Change to discontinue redundant in-process QC tests for purified antibodies and antigens. |
P060027/S071 12/16/14 |
Paradym CRT-D 8750, Paradym RF CRT-D 9750, Paradym RF CRT-D 9750, Intensia CRT-D |
Sorin CRM USA, Inc. Arvada, CO 80004 |
Addition of a C-Mode Scanning Acoustic Microscopy system in the manufacturing assembly line. |
P060028/S003 12/15/14 |
MEMORYSHAPE Breast Implants | Mentor Worldwide LLC Somerville, NJ 08876 |
Change to automate the existing silicone elastomer sheet cutter used to cut part components for Mentor Saline-Filled and SPECTRUM Breast Implants, Mentor MemoryGel Silicone Gel-Filled Breast Implants and Mentor MemoryShape Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
P060028/S004 12/16/14 |
MEMORYSHAPE Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to automate the manual Secondary Packaging process to be used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility. |
P060033/S093 12/10/14 |
Endeavor Sprint Zotarolimus-Eiuting Coronary Stent System | Medtronic Santa Rosa, CA 95403 |
Option to sterilize using Cycle #3 on Lines 9 and 3, changing the Resolute Integrity’s pallet configuration, and co-sterilization of all similar DES devices (including those commercialized outside of US). |
P060035/S024 12/11/14 |
ARCHITECT CORE-M | Abbott Laboratories Abbott Park, IL 60064 |
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices. |
P060037/S033 12/30/14 |
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee | Zimmer, Inc. Warsaw, IN 46581 |
Change in the cleaning process. |
P080011/S032 12/17/14 |
Biofinity (comfilcon A) extended‐wear, soft (hydrophilic) contact lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Approval for the use of an alternate pick head material, for the manufacture of comfilcon A extended-wear contact lenses. |
P080023/S026 12/11/14 |
ARCHITECT CORE | Abbott Laboratories Abbott Park, IL 60064 |
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices. |
P080025/S082 12/22/14 |
INTERSTIM THERAPY SYSTEM | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Change the sampling strategy for the special manufacturing process monitoring. |
P080026/S013 12/10/14 |
Abbott RealTime HBV | Abbott Molecular, Incorporated Des Plaines, IL 60018 |
Change to the equipment utilized for identity testing of oligonucleotides at the contract testing laboratory. |
P080029/S002 12/18/14 |
Quick-close Vascular Suturing System | Interventional Therapies, LLC. Wilton, CT 06897 |
Change to the dimensional tolerances of the cannula and modifications to the bonding process for two device subassemblies. |
P090013/S162 12/12/14 |
Revo MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
Modifications to the in-process battery inspection requirements for the batteries used in the devices. |
P090013/S163 12/19/14 |
Revo MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the devices. |
P100009/S008 12/17/14 |
MitraClip Delivery System | Abbott Vascular, Inc. Menlo Park, CA 94025 |
Changes related to the laser welding supplier and associated incoming inspections. |
P100009/S009 12/22/14 |
MitraClip Delivery System | Abbott Vascular, Inc. Menlo Park, CA 94025 |
Implementation of an additional ethylene oxide sterilization chamber at the current sterilization facility. |
P100017/S011 12/10/14 |
Abbott RealTime HCV | Abbott Molecular, Incorporated Des Plaines, IL 60018 |
Change to the equipment utilized for identity testing of oligonucleotides at the contract testing laboratory. |
P100021/S043 12/19/14 |
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac Stent Graft System, Endurant IIs Stent Graft System | Medtronic Inc. Santa Rosa, CA 95403 |
Addition of new wire forming machines to the stent ring manufacturing line. |
P100023/S111 12/18/14 |
ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Add additional lines for the manufacture of the stent delivery catheter outer component at the Galway Ireland manufacturing facility. |
P100024/S006 12/29/14 |
HER2 CISH pharmDx™ Kit | Dako Denmark A/S Glostrup, Denmark 2600 |
Modification of the quality control for incoming Alu-PNAs materials to reduce high background signal in the negative controls. |
P100026/S025 12/22/14 |
Neuropace RNS System | Neuropace, Inc. Mountain View, CA 94053 |
Update the equipment software. |
P100027/S020 12/4/14 |
INFORM HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Change in the manufacturing parameters for the Ventana reagent dispenser vent seal. |
P100029/S018 12/12/14 |
Trifecta™ Valve | St. Jude Medical, Inc. St. Paul, MN 55117 |
Alternate batch sampling/testing strategy for bacterial endotoxin testing (BET). |
P100047/S051 12/4/14 |
HeartWare Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Automate various manufacturing processes. |
P100047/S052 12/11/14 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Add a mechanized HVAD® housing gluing process for the HeartWare® Ventricular Assist System. |
P100047/S054 12/19/14 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Add an alternate supplier for a component of the HeartWare Ventricular Assist System Pump. |
P110002/S008 12/29/14 |
Mobi-C Cervical Disc Prosthesis | LDR Spine USA, Inc. Austin, TX 78750 |
Addition of a manufacturing machine and a cleaning process equipment change. |
P110009/S008 12/29/14 |
Mobi-C Cervical Disc Prosthesis | LDR Spine USA, Inc. Austin, TX 78750 |
Addition of a manufacturing machine and a cleaning process equipment change. |
P110010/S100 12/18/14 |
PROMUS Element™ Plus/ Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent Systems | Boston Scientific Corporation Maple Grove, MN 55311 |
Add additional lines for the manufacture of the stent delivery catheter outer component at the Galway Ireland manufacturing facility. |
P110013/S047 12/10/14 |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Option to sterilize using Cycle #3 on Lines 9 and 3, changing the Resolute Integrity’s pallet configuration, and co-sterilization of all similar DES devices (including those commercialized outside of US). |
P110013/S048 12/16/14 |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Modification to the test method used to determine the water content in the Zotarolimus drug. |
P110023/S013 12/10/14 |
EverFlex Self-Expanding Peripheral Stent System | ev3, Inc. Plymouth, MN 55441 |
Change in the rinse solution for the pre-clean bath prior to electropolishing. |
P110029/S018 12/11/14 |
ARCHITECT HBsAg Qualitative/ ARCHITECT HBsAg Qualitative Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices. |
P110029/S019 12/17/14 |
ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Scale up the manufacturing batch size for the microparticle concentrates. |
P110029/S020 12/30/14 |
ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory | Abbott Laboratories, Diagnostics Division Abbott Park, IL 60064 |
Change to discontinue redundant in-process QC tests for purified antibodies and antigens. |
P110038/S008 12/12/14 |
Relay Thoracic Stent-graft With Plus Delivery System | Bolton Medical, Inc. Sunrise, FL 33325 |
Alternate supplier for medical grade polyvinyl chloride. |
P120005/S030 12/12/14 |
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Manufacturing change in the layer application process for the G4 PLATINUM Sensor, which is a component of the Dexcom G4™ PLATINUM Continuous Glucose Monitoring System. |
P120006/S018 12/18/14 |
Ovation and Ovation Prime Abdominal Stent Graft System | Trivascular Inc. Santa Rosa, CA 95403 |
Modifications to the equipment for stent graft loading. |
P120008/S007 12/11/14 |
ARCHITECT AFP | Abbott Laboratories Abbott Park, IL 60064 |
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices. |
P120010/S043 12/3/14 |
MiniMed 530G System | Medtronic MiniMed Inc. Northridge, CA 91325 |
Change to a rejection criterion in the harvest of used motors during the manufacturing of refurbished pumps. The motor is a part of the insulin pump in the Paradigm REAL-Time System (MMT-522, MMT-722, MMT-522K, MMT-722K), the Paradigm REALTime Revel System (MMT-523, MMT-723, MMT-523K, MMT-723K), and the MiniMed 530G System (MMT-551, MMT-751). |
P120010/S045 12/14/14 |
Minimed 530G System | Medtronic, Inc. Northridge, CA 91325 |
Implementation of five additional pieces of equipment at a contract manufacturer to support the manufacture of the lithium polymer batteries for the MiniLink REAL-Time Transmitter model number MMT-7703 and the iPro2 Digital Recorder model number MMT-7741. The MiniLink Transmitter is a component of the Paradigm REAL‐ Time System, Paradigm REAL‐ Time Revel System, Guardian Real‐Time System, MiniLink REAL‐Time System, as well as the MiniMed 530G System. The iPro2 Recorder is a component of the iPro2 Professional Continuous Glucose Monitoring System. |
P120010/S047 12/19/14 |
MiniMed 530G System | Medtronic, Inc. Northridge, CA 91325 |
Reprogramming of new PC boards/ stacks for the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K, MMT-723, MMT-723K), and MiniMed 530G Insulin Pump (Models: MMT-551, MMT-751) in Medtronic Puerto Rico Operations Co. (MPROC). The Paradigm REAL-Time Insulin Pump, Paradigm REAL-Time Revel Insulin Pump, and MiniMed 530G Insulin Pump are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, and MiniMed 530G System, respectively. |
P120010/S048 12/31/14 |
MiniMed 530G System | Medtronic, Inc. Northridge, CA 91325 |
Addition of the Medtronic Juncos Lab as a site for endotoxin testing for the Enlite Sensor that is part of the MiniMed 530G System. |
P120012/S006 12/10/14 |
Abbott RealTime HCV Genotype II | Abbott Molecular, Incorporated Des Plaines, IL 60018 |
Change to the equipment utilized for identity testing of oligonucleotides at the contract testing laboratory. |
P120022/S002 12/19/14 |
therascreen® EGFR RGQ PCR Kit | QIAGEN Manchester, United Kingdom M15 6SH |
Change to the manufacturing method of the Positive Control (PC) in the EGFR RGQ PCR kit. The change in manufacturing method includes an adjustment step of an in-process procedure to ensure that targeted amounts of each oligonucleotide within the PC are calculated to achieve the target crossing threshold (Ct). |
P130009/S017 12/5/14 |
Novaflex + Delivery System, Edwards Expandable Introducer Sheath Set, Ascendra+ Delivery System, Ascendra+ Introducer Sheath Set | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Implement an automated data analysis spreadsheet used during product verification testing. |
P130009/S009 12/15/14 |
Edwards SAPIEN XT™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvin, CA 92614 |
Change to the ink hardener used in the pad printing of graphics onto the NovaFlex+ Delivery System and the Edwards Expandable Introducer Sheath Set. |
P130021/S009 12/15/14 |
Medtronic CoreValve System | Medtronic CoreValve LLC Santa Rosa, CA 95403 |
Modify the acceptance criteria for the parameters measured by the functional tester equipment. |