Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 45
Summary of PMA Originals Under Review
Total Under Review: 52
Total Active: 20
Total On Hold: 32
Summary of PMA Supplements Under Review
Total Under Review: 600
Total Active: 415
Total On Hold: 185
Summary of All PMA Submissions Received
Originals: 3
Supplements: 87
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 45
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 141.4
FDA Time: 109.3 Days MFR Time: 32.1 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P100026 11/14/13 |
RNS® System | NeuroPace, Inc. Mountain View, CA 94043 |
Approval for the RNS® System. This device is indicated as follows: " … as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/ or secondarily generalized seizures). The RNS® System has demonstrated safety and effectiveness in patients who average 3 or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures), and has not been evaluated in patients with less frequent seizures." |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790007/S040 11/14/13 Real-Time |
Hancock® Modified Orifice (MO) Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for a design change to the rubber gasket for the jar used to package the device. |
| P810006/S036 11/29/13 135-Day |
CollaStat Absorbable Collagen Hemostatic Sponge, CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar Form | Integra Life Sciences Corporation Plainsboro, NJ 08536 |
Approval for the following proposed changes: 1) change in cleaning detergents; 2) establishment of equipment Dirty Hold times (DHT); and 3) proposed use of Total Organic Carbons (TOCs) as a method to test for residues. |
| P830055/S129 11/29/13 180-Day |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for manufacturing sites located at STERIS Isomedix, Chester, New York, and Synergy Health Switzerland, Däniken, Switzerland. Both facilities will perform sterilization operations for the LCS Total Knee System. |
| P840062/S025 11/29/13 135-Day |
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery | Integra Life Sciences Corporation Plainsboro, NJ 08536 |
Approval for the following proposed changes: 1) change in cleaning detergents; 2) establishment of equipment Dirty Hold times (DHT); and 3) proposed use of Total Organic Carbons (TOCs) as a method to test for residues. |
| P850010/S033 11/29/13 135-Day |
HeliStat, Helitene Absorbable Collagen Hemostatic Agents | Integra Life Sciences Corporation Plainsboro, NJ 08536 |
Approval for the following proposed changes: 1) change in cleaning detergents; 2) establishment of equipment Dirty Hold times (DHT); and 3) proposed use of Total Organic Carbons (TOCs) as a method to test for residues. |
| P870078/S024 11/14/13 Real-Time |
Hancock® Low- Porosity Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for a design change to the rubber gasket for the jar used to package the device. |
| P890003/S292 11/22/13 180-Day |
CareLink Monitor, CardioSight Reader and Device Data Management Application | Medtronic, Inc. Mounds View, MN 55112 |
Approval of the post-approval study protocol. |
| P890047/S042 11/13/13 180-Day |
PROVISC® Improved Buffering Capacity (IBC) Ophthalmic Viscosurgical Device | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval to discontinue the current intravitreal test and replace it with the Inflammatory Release Assay for the PROVISC® IBC ophthalmic viscosurgical device. |
| P900033/S027 11/29/13 135-Day |
Integra Dermal Regeneration Template | Integra Life Sciences Corporation Plainsboro, NJ 08536 |
Approval for the following proposed changes: 1) change in cleaning detergents; 2) establishment of equipment Dirty Hold times (DHT); and 3) proposed use of Total Organic Carbons (TOCs) as a method to test for residues. |
| P920015/S117 11/22/13 180-Day |
Sprint Quattro Secura Defibrillators Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval of the post-approval study protocol. |
| P970003/S146 11/26/13 180-Day |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Approval for a labeling update to include the results of the D-21 Post Approval Study. |
| P970020/S077 11/26/13 135-Day |
MULTILINK ULTRA RX and OTW Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
Approval for a change to the in-process stent sub-assembly inspection process. |
| P970051/S107 11/13/13 135-Day |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for introduction of a contained Helium leak test. |
| P980016/S441 11/22/13 180-Day |
Secura DR, Secura VR, Maximo II DR Maximo II VR Implantable Cardioverter Defibrillators | Medtronic, Inc. Mounds View, MN 55112 |
Approval of the post-approval study protocol. |
| P980018/S018 11/26/13 Special |
HercepTest™ | Dako Denmark A/S Glostrup, Denmark 2600 |
Approval for labeling changes made to enhance safety of HercepTest™ when used for gastric and gastroesophageal cancer indications. |
| P000037/S033 135-Day 11/14/13 |
On-x Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78752 |
Approval for several changes to the routine sterilization process. |
| P010013/S050 11/8/13 180-Day |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Approval of the post-approval study protocol. |
| P010030/S402 11/22/13 180-Day |
Consula CRT-D, Maximo II CRT-D Implantable Cardioverter Defibrillators with Resynchronization, Model 9995 Application Software v1.2 Systems | Medtronic, Inc. Mounds View, MN 55112 |
Approval of the post-approval study protocol. |
| P010047/S028 11/8/13 180-Day |
NeoMend Progel® Pleural Air Leak Sealant and Progel® Extended Applicator Spray Tip | Neomend, Inc. Irvine, CA 92618 |
Approval of the post-approval study protocol. |
| P020024/S040 11/8/13 180-Day |
Amplatzer Duct Occluder II | AGA Medical Corporation Plymouth, MN 55442 |
Approval of the post-approval study protocol. |
| P020025/S045 11/25/13 Real-Time |
IntellaTip Mifi Xp Ablation Catheter and Accessories | Boston Scientific Corporation San Jose, CA 95134 |
Approval to allow health care facilities to manually clean and re-sterilize the IntellaTip Mifi XP cable up to 10 times via ethylene oxide or steam after initial use of the cables. |
| P020025/S046 11/25/13 Real-Time |
IntellaTip Mifi Xp Ablation Catheter and Accessories | Boston Scientific Corporation San Jose, CA 95134 |
Approval to change the shelf life of the IntellaTip Mifi XP ablation catheter from 6 months to 3 years. |
| P020050/S010 11/25/13 180-Day |
WaveLight EX500 Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for a registration feature that enables Pupil Center Shift Compensation and Cyclotorsion Adjustment based on comparison of diagnostic and treatment images. |
| P030008/S009 11/25/13 180-Day |
WaveLight EX500 Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for a registration feature that enables Pupil Center Shift Compensation and Cyclotorsion Adjustment based on comparison of diagnostic and treatment images. |
| P030054/S246 11/14/13 Real-Time |
Left Ventricular Lead Families | St. Jude Medical Sylmar, CA 91342 |
Approval for a modification to the weld shaft component on 1258T and 1458Q lead families. |
| P040021/S024 11/7/13 135-Day |
Biocor/Epic™ Valve | St. Jude Medical St. Paul, MN 55117 |
Approval for an alternate vendor for the jar and lid components as well as a change to the jar tooling. |
| P040034/S021 11/15/13 135-Day |
DuraSeal Dural Sealant System | Covidien North Haven, CT 06473 |
Approval for a change to the layering of kits in the case box used for sterilization. |
| P050034/S009 11/5/13 180-Day |
Implantable Miniature TelescopeTM (IMT) | VisionCare Ophthalmic Technologies Saratoga, CA 95070 |
Approval for modifications to the approved Professional Use Information and Patient Information Booklet to add information obtained from Post-Approval Study IMT-002- LTME. |
| P050044/S025 11/15/13 180-Day |
Vitagel® RT3™ Surgical Hemostat | Orthovita, Inc. “dba” Stryker Orthobiologics Malvern, PA 19355 |
Approval for a device name change for the Vitagel® RT Surgical Hemostat. The device, as modified, will be marketed under the trade name Vitagel® RT3™ Surgical Hemostat with no change in the indications for use. |
| P050047/S031 11/26/13 Real-Time |
Juvéderm Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Approval for change to the concentration of the lidocaine solution introduced to the gel during the homogenization step from 50% w/w to 30% w/v lidocaine hydrochloride and a revalidation, by weight, the amount of gel that can be mixed during the homogenization step of the manufacturing process. |
| P060039/S049 11/19/13 180-Day |
Attain StarFix | Medtronic, Inc. Mounds View, MN 55112 |
Approval of the post-approval study protocol. |
| P070026/S016 11/21/13 180-Day |
CERAMAX® Ceramic Total Hip System | DePuy Synthes Warsaw, IN 46581 |
Approval of the post-approval study. |
| P080013/S009 11/15/13 135-Day |
DuraSeal Exact Spine Sealant System | Covidien North Haven, CT 06473 |
Approval for a change to the layering of kits in the case box used for sterilization. |
| P090018/S024 11/4/13 Real-Time |
Esteem | Envoy Medical Corporation Saint Paul, MN 55110 |
Approval for changes to the Intraoperative System Analyzer (ISA) software. |
| P100029/S016 11/7/13 135-Day |
Trifecta™ Valve | St. Jude Medical St. Paul, MN 55117 |
Approval for an alternate vendor for the jar and lid components as well as a change to the jar tooling. |
| P100030/S001 11/25/13 Real-Time |
ArterX® Surgical Sealant | Tenaxis Medical, Inc. Mountain View, CA 94043 |
Approval for the addition of 2.5mL and 5.0mL fill volumes to the existing 4.0mL fill volume, using the same 5mL syringe and packaging. |
| P100030/S002 11/5/13 Real-Time |
ArterX Surgical Sealant | Tenaxis Medical, Inc. Mountain View, CA 94043 |
Approval to extend the shelf life for ArterX Surgical Sealant from 12 months to 24 months when stored at 2-8°C and to extend the shelf life for the ArterX Delivery Tips from 12 months to 42 months. |
| P100041/S043 11/18/13 Special |
Edwards SAPIEN™ Transcatheter Heart Valve and Transfemoral Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for modifying inspection of the y-connector to guidewire shaft and associated changes to the manufacturing procedure documentation. |
| P100047/S024 11/15/13 180-Day |
HeartWare Ventricular Assist System | HeartWare, Inc. Miami, FL 33014 |
Approval of the post-approval study. |
| P100047/S025 11/15/13 180-Day |
HeartWare Ventricular Assist System | HeartWare, Inc. Miami, FL 33014 |
Approval of the post-approval study. |
| P110010/S053 111/21/13 180-Day |
Promus PREMIER™ Everolimus-Eluting Platinum-Chromium Coronary Stent System (Monorail™ and Over-The-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the following changes to the PROMUS® Element™ Plus Everolimus-Eluting Platinum-Chromium Coronary Stent System: stent design modifications to increase axial strength, a shorter tip and colorant change on the stent delivery system, modifications to the hypotube covering on the stent delivery system, and labeling changes. The device, as modified, will be marketed under the trade name Promus PREMIER™ Everolimus- Eluting Platinum Chromium Coronary Stent System. |
| P110013/S015 11/7/13 135-Day |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for changes to the components and the software of the drug spray machine. |
| P110021/S030 11/18/13 Special |
Edwards SAPIENTM Transcatheter Heart Valve and Transfemoral and Transapical Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for modifying inspection of the y-connector to guidewire shaft and associated changes to the manufacturing procedure documentation. |
| P110032/S006 11/21/13 Special |
Aorfix™ AAA Flexible Stent Graft System | Lombard Medical Technologies, Inc. Tempe, AZ 85284 |
Approval for revised Instructions for Use (IFU) to add warnings and precautions based on data from ongoing follow-up of subjects in the IDE study. |
| P120007/S001 11/6/13 180-Day |
APTIMA® HPV 16 18/45 Genotype Assay | Gen-Probe Incorporated San Diego, CA 92121 |
Approval for the addition of the PANTHER System to the APTIMA® HPV 16 18/45 Genotype Assay. The device, as modified, will be marketed under the trade name APTIMA® HPV 16 18/45 Genotype Assay. The APTIMA HPV 16 18/45 Genotype Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 45 in cervical specimens from women with APTIMA HPV Assay positive results. The APTIMA HPV 16 18/45 Genotype Assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the APTIMA HPV 16 18/45 Genotype Assay. The assay is used with the TIGRIS DTS System or the PANTHER System. The use of the test is indicated: 1) In women 21 years and older with atypical squamous cells of undetermined significance (AS-CUS) cervical cytology results, the APTIMA HPV 16 18/45 Genotype Assay can be used to test samples from women with APTIMA HPV Assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy; and 2) In women 30 years and older, the APTIMA HPV 16 18/45 Genotype Assay can be used to test samples from women with APTIMA HPV Assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. *Broom-type device (e.g., Wallach Pipette) or endocervical brush/spatula. |
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 |
|---|---|---|---|
| N970003/S157 11/26/13 |
FORMIO, VITALIO, ADVANTIO, INGENIO, ALTRUA, INSIGNIA Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Add instructions for cleaning the seal plug bond area of the polyurethane headers of the devices to the appropriate work instructions. |
| P820003/S125 11/19/13 |
Disposable EPG Cover | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P830061/S099 11/19/13 |
CapSure, Viatron Lead families | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P830061/S100 11/26/13 |
CapSure, Viatron Lead Families | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P840001/S254 11/20/13 |
RestoreAdvanced® Neurostimulator; RestoreAdvanced® MRI Rechargeable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Changes to the manufacturing test methodology (final functional test) for hybrids that are used to build implantable neurostimulators. |
| P840001/S255 11/22/13 |
Itrel 4 Implantable Neurostimulator, Itrel 3 Implantable Neurostimulator RestorePrime Implantable Neurostimulator PrimeAdvanced Implantable Neurostimulator, Restore Implantable Neurostimulator, RestoreUltra Implantable Neurostimulator, RestoreAdvanced Implantable Neurostimulator, RestoreSensor Implantable Neurostimulator, PrimeAdvanced SureScan MRI Neurostimulator, RestoreUltra SureScan MRI Rechargeable Neurostimulator, RestoreAdvanced SureScan MRI Rechargeable Neurostimulator, RestoreSensor SureScan MRI Rechargeable Neurostimulator, Synergy Implantable Neurostimulator | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Addition of a new epoxy mixer component for the MTA epoxy dispenser at Medtronic final assembly device manufacturing facility for the affected products. |
| P840001/S256 11/27/13 |
Revision Kit, 1×8 Subcompact Lead Kit, 1×8 Standard Lead Kit, 1×8 Compact Lead Kit, Octad Lead, 1×8 Low Impedance Lead Kit, 1×8 Compact Low Impedance Lead Kit, Vectris SureScan MRI 1×8 Subcompact, Vectris SureScan MRI 1×8 Subcompact, Vectris SureScan MRI 1×8 Subcompact, Vectris SureScan MRI 1×8 Compact, Vectris SureScan MRI 1×8 Compact, Vectris SureScan MRI 1×8 Compact, Pisces-Quad Lead Kit, Pisces-Quad Compact Lead Kit, Pisces-Quad Plus Lead Kit, Lead Revision Kit, Lead Revision Kit, 1×8 Lead Revision Accessory Kit, 1×8 Lead Revision Accessory Kit, Vectris 1×8 Subcompact, Vectris 1×8 Compact | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Move the manufacturing of the guidewire from one building to another building on the same campus. |
| P850089/S102 11/19/13 |
CapSure SP, Capsure Z, Viatron II Lead Families | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P850089/S103 11/26/13 |
CapSure SP, Capsure Z, Viatron II Lead Families | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P860057/S114 11/26/13 |
Carpentier-Edwards PERIMOUNT Bioprosthesis | Edwards Lifesciences, LLC Irvine,CA 92614 |
Addition of a new clean room and two additional pieces of associated equipment at an existing manufacturing facility. |
| P890003/S289 11/19/13 |
CapSure Leads, Pacemaker Repair Kit | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P890003/S291 11/26/13 |
CapSure leads, Pacemaker Repair Kit | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P890057/S021 11/22/14 |
CareFusion 3100 High Frequency Oscillating Ventilator (HFOV) | CareFusion Yorba Linda, CA 92887 |
Change to add a supplier for the stopcock. |
| P900061/S123 11/19/13 |
Epicardial Patch Lead, ACE Header, End Cap | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P900061/S124 11/26/13 |
Epicardial Patch Lead, ACE Header, End Cap | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P910007/S040 11/26/13 |
ARCHITECT Total PSA | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Replacement of a quality control test with a new quality control test for an incoming raw material. |
| P910007/S041 11/26/13 |
ARCHITECT Total PSA | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Addition of a quality control test method for incoming lots of Triton X-100. |
| P910023/S322 11/26/13 |
Fortify ICDs | St. Jude Medical Sylmar, CA 91342 |
Change to a tool used during device manufacturing. |
| P920015/S121 11/19/13 |
Transvene Leads, Sprint Quattro Lead Family, Y-Adaptor, Pin Plug | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P920015/S123 11/26/13 |
Transvene Leads, Sprint Quattro Lead Family, Y-Adaptor, Pin Plug | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P930029/S095 11/19/13 |
CapSureFix, SureFix, TorClip | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P930039/S096 11/26/13 |
CapSureFix, SureFix, TorClip | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P950005/S048 11/26/13 |
Celsius FLTR Bi-directional Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change to the oven parameters in the tip reflow process and implementation of a new inspection. |
| P950008/S011 11/22/13 |
SILIKON 1000 Retinal Tamponade | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Alternate reagent supplier. |
| P950024/S053 11/19/13 |
CapSure Epicardial Leads | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P950024/S054 11/26/13 |
CapSure Epicardial Leads | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P950029/S085 11/26/13 |
Reply SR, Reply DR, Esprit SR, Esprit DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Alternate equipment for polymerization, plasma cleaning, and wire bonding that is used to manufacture the devices. |
| P960009/S185 11/22/13 |
Activa PC Implantable Neurostimulator, Activa SC Implantable Neurostimulator, Activa RC Implantable Neurostimulator, Soletra Implantable Neurostimulator | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Addition of a new epoxy mixer component for the MTA epoxy dispenser at Medtronic final assembly device manufacturing facility for the affected products. |
| P960040/S307 11/26/13 |
PUNCTUA, TELIGEN, ENERGEN, INCEPTA, VITALITY, Implantable Cardioverter Defibrillators (ICDs) | Boston Scientific Corporation St. Paul, MN 55112 |
Add instructions for cleaning the seal plug bond area of the polyurethane headers of the devices to the appropriate work instructions. |
| P970004/S164 11/22/13 |
InterStim Implantable Neurostimulator, InterStim II Implantable Neurostimulator | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Addition of a new epoxy mixer component for the MTA epoxy dispenser at Medtronic final assembly device manufacturing facility for the affected products. |
| P970020/S078 11/14/13 |
MULTILINK ZETA CSS | Abbott Vascular Temecula, CA 92591 |
Addition of an alternate supplier for the adaption cup components used to manufacture the devices. |
| P980007/S031 11/26/13 |
ARCHITECT Free PSA | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Replacement of a quality control test with a new quality control test for an incoming raw material. |
| P980007/S032 11/26/13 |
ARCHITECT Free PSA | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Addition of a quality control test method for incoming lots of Triton X-100. |
| P980016/S445 11/19/13 |
Evera, Maximo, Protecta, Secura, Virtuoso ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P980024/S011 11/27/13 |
PathVysion HER-2 DNA Probe Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Changing the configuration of their current label printer, label printing software, and label inspection system for the following FISH assays: Vysis ALK Break Apart Fish Probe Kit, UroVysion Bladder Cancer Kit, and PathVysion Her-2DNA Probe Kit. |
| P980035/S349 11/14/13 |
Advisa DR MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
Addition of a second laser welder to the battery manufacturing line of the devices. |
| P980035/S350 11/14/13 |
Advisa DR IPG and Advisa DR MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
Use of an additional leak test station at the battery supplier. |
| P980035/S351 11/19/13 |
Advisa DR IPG and Advisa DR MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
Modification in a laser seam welder. |
| P980035/S352 11/21/13 |
Adapta, Versa, and Sensia IPGs | Medtronic CRDM Mounds View, MN 55112 |
Modification to the laser ribbon bonding processing parameters. |
| P980035/S353 11/19/13 |
Advisa DR IPG, Advisa DR MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Additional workstations used at the medium rate battery supplier. |
| P980035/S354 11/19/13 |
Adapta, Vera, Sensia, Advisa, Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P980049/S089 11/26/13 |
Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Alternate equipment for polymerization, plasma cleaning, and wire bonding that is used to manufacture the devices. |
| P980050/S086 11/19/13 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P980050/S087 11/26/13 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P990081/S023 11/15/13 |
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Automation of testing processes (currently performed semi-manually) using the new automated Dispenser Verification Module (DVM). |
| P010012/S342 11/26/13 |
COGNIS, ENERGEN, INCEPTA, PUNCTUA Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) | Boston Scientific Corporation St. Paul, MN 55112 |
Add instructions for cleaning the seal plug bond area of the polyurethane headers of the devices to the appropriate work instructions. |
| P010015/S223 11/14/13 |
Consulta CRT-P and Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Use of an additional leak test station at the battery supplier. |
| P010015/S224 11/19/13 |
Consulta CRT-P, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Additional workstations used at the medium rate battery supplier. |
| P010015/S225 11/19/13 |
Attain OTW leads, Consulta CRT-P, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P010015/S226 11/26/13 |
Attain OTW and LV leads | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P010031/S406 11/19/13 |
Brava, Concerto, Consulta, Maximo, Protecta, Viva CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P010068/S037 11/26/13 |
Celsius FLTR Uni-directional Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Change to the oven parameters in the tip reflow process and implementation of a new inspection. |
| P020004/S088 11/25/13 |
EXCLUDER AAA Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
Implement the use of alternate polytetrafluoroethylene (PTFE) resin raw material. |
| P020047/S056 11/14/13 |
VISION RX, MINI VISION RX, MULTILINK 8 Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Addition of an alternate supplier for the adaption cup components used to manufacture the devices. |
| P020055/S011 11/15/13 |
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Automation of testing processes (currently performed semi-manually) using the new automated Dispenser Verification Module (DVM). |
| P030005/S104 11/26/13 |
INVIVE, INTUA, Cardiac Resynchronization Therapy-Pacemakers (CRT-Ps) | Boston Scientific Corporation St. Paul, MN 55112 |
Add instructions for cleaning the seal plug bond area of the polyurethane headers of the devices to the appropriate work instructions. |
| P030036/S065 11/19/13 |
SelectSecure Lead, Lead Anchor Sleeve | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P030036/S066 11/26/13 |
SelectSecure Lead, Lead Anchor Sleeve | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P030052/S013 11/27/13 |
UroVysion Bladder Cancer Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Changing the configuration of their current label printer, label printing software, and label inspection system for the following FISH assays: Vysis ALK Break Apart Fish Probe Kit, UroVysion Bladder Cancer Kit, and PathVysion Her-2DNA Probe Kit. |
| P030054/S253 11/26/13 |
Unify and Unify Quadra CRT-Ds | St. Jude Medical Sylmar, CA 91342 |
Change to a tool used during device manufacturing. |
| P040037/S058 11/24/13 |
GORE VIABAHN Endoprosthesis | W. L. Gore & Associates, Inc. Flagstaff, AZ 86005 |
Modify the process settings of a bonding process. |
| P040037/S059 11/25/13 |
TAG Thoracic Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
Implement the use of alternate polytetrafluoroethylene (PTFE) resin raw material. |
| P040047/S030 11/21/13 |
Coaptite Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Elimination of a redundant drying test. |
| P050006/S037 11/25/13 |
HELEX Septal Occluder | W.L. Gore & Associates Flagstaff, AZ 86001 |
Implement the use of alternate polytetrafluoroethylene (PTFE) resin raw material. |
| P050037/S043 11/27/13 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Elimination of a test performed on the Radiesse Dermal Filler. |
| P050042/S026 11/15/13 |
ARCHITECT Anti-HCV | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Change to a test method for evaluation of incoming and recalcified anti-HCV negative human plasma. |
| P050042/S027 11/26/13 |
ARCHITECT Anti-HCV | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Replacement of a quality control test with a new quality control test for an incoming raw material. |
| P050042/S028 11/26/13 |
ARCHITECT Anti-HCV | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Addition of a quality control test method for incoming lots of Triton X-100 |
| P050051/S023 11/26/13 |
ARCHITECT AUSAB | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Replacement of a quality control test with a new quality control test for an incoming raw material. |
| P050051/S024 11/26/13 |
ARCHITECT AUSAB | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Addition of a quality control test method for incoming lots of Triton X-100 |
| P050052/S046 11/27/13 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Elimination of a test performed on the Radiesse Dermal Filler. |
| P060027/S057 11/26/13 |
Paradym CRT-D, Paradym RF CRT-D | Sorin CRM USA, Inc. Arvada, CO 80004 |
Alternate equipment for polymerization, plasma cleaning, and wire bonding that is used to manufacture the devices. |
| P060035/S021 11/26/13 |
ARCHITECT CORE-M | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Replacement of a quality control test with a new quality control test for an incoming raw material. |
| P060035/S022 11/26/13 |
ARCHITECT CORE-M | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Addition of a quality control test method for incoming lots of Triton X-100 |
| P060038/S018 11/22/13 |
Mitroflow Aortic Pericardial Heart Valve | Sorin Group USA, Inc. Arvada, CO 80004 |
Change the supplier to perform analysis on receiving materials from an external contract laboratory to in-house. |
| P060039/S049 11/19/13 |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval of the post-approval study protocol. |
| P060039/S052 11/19/13 |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P060039/S053 11/26/13 |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P070015/S115 11/14/13 |
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) and XIENCE nano EECSS (XIENCE nano) | Abbott Vascular Temecula, CA 92591 |
Addition of an alternate supplier for the adaption cup components used to manufacture the devices. Edwards SAPIEN™ Transcatheter Heart Valve and Accessories. |
| P070015/S116 11/20/13 |
Xience V Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Addition of receiving inspection and testing activities of drug materials at the Clonmel, Ireland facility and a contract laboratory. |
| P080006/S059 11/19/13 |
Attain Ability Lead Family | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P080006/S060 11/26/13 |
Attain Ability Lead Family | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P080023/S023 11/26/13 |
ARCHITECT CORE | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Replacement of a quality control test with a new quality control test for an incoming raw material. |
| P080023/S024 11/26/13 |
ARCHITECT CORE | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Addition of a quality control test method for incoming lots of Triton X-100. |
| P080025/S060 11/22/13 |
InterStim Implantable Neurostimulator, InterStim II Implantable Neurostimulator | Medtronic, Inc. Neuromodulation Minneapolis, MN 55432 |
Addition of a new epoxy mixer component for the MTA epoxy dispenser at Medtronic final assembly device manufacturing facility for the affected products. |
| P080026/S010 11/19/13 |
Abbott RealTime HBV Assay | Abbott Molecular Des Plaines, IL 60018 |
Manufacturing process changes and QC in-process method changes to synthesize oligonucleotides on a larger scale. |
| P090013/S116 11/14/13 |
Revo MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
Addition of a second laser welder to the battery manufacturing line of the devices. |
| P090013/S117 11/14/13 |
Revo MRI IPG | Medtronic CRDM Mounds View, MN 55112 |
Use of an additional leak test station at the battery supplier. |
| P090013/S118 11/19/13 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Additional workstations used at the medium rate battery supplier. |
| P090013/S119 11/19/13 |
CapSureFix MRI Lead, Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Remove the annual requirement for Ethylene Oxide residual testing at Medtronic final device manufacturing facilities. |
| P090013/S120 11/26/13 |
CapSureFix MRI Lead, Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Reduce the exposure time during ethylene-oxide half-cycle testing at Medtronic final device manufacturing facilities. |
| P100017/S008 11/19/13 |
Abbott RealTime HCV Assay | Abbott Molecular Des Plaines, IL 60018 |
Manufacturing process changes and QC in-process method changes to synthesize oligonucleotides on a larger scale. |
| P100027/S012 11/15/13 |
INFORM HER2 Dual ISH DNA Probe | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Automation of testing processes (currently performed semi-manually) using the new automated Dispenser Verification Module (DVM). |
| P100041/S042 11/26/13 |
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Implementation of an automated tube cutting fixture to replace manual cutting. |
| P110012/S005 11/27/13 |
Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Changing the configuration of their current label printer, label printing software, and label inspection system for the following FISH assays: Vysis ALK Break Apart Fish Probe Kit, UroVysion Bladder Cancer Kit, and PathVysion Her-2DNA Probe Kit. |
| P110019/S056 11/14/13 |
XIENCE PRIME EECSS (XIENCE PRIME and XIENCE PRIME Long Lengths) | Abbott Vascular Temecula, CA 92591 |
Addition of an alternate supplier for the adaption cup components used to manufacture the devices. |
| P110019/S057 11/14/13 |
Xience Prime Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Addition of receiving inspection and testing activities of drug materials at the Clonmel, Ireland facility and a contract laboratory. |
| P110021/S029 11/26/13 |
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences LLC Irvine, CA 92614 |
Implementation of an automated tube cutting fixture to replace manual cutting. |
| P110029/S014 11/26/13 |
ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Replacement of a quality control test with a new quality control test for an incoming raw material. |
| P110029/S015 11/26/13 |
ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Addition of a quality control test method for incoming lots of Triton X-100. |
| P110029/S016 11/26/13 |
ARCHITECT HBsAg Qualitative and Qualitative Confirmatory | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Change in an incoming Quality Control method for anti-HBs negative plasmas. |
| P110035/S023 11/24/13 |
Epic Vascular Self-Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change the data collection method and frequency in the extrusion manufacturing process. |
| P110037/S012 11/26/13 |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Adjustment to the pH range for the Lysis Reagent. |
| P110040/S001 11/24/13 |
Complete SE Vascular Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Modify the bonding process for the stability member subcomponent of the delivery system. |
| P110042/S018 11/21/13 |
S-ICD System | Cameron Health, Inc. San Clemente, CA 92673 |
Implement an automated High Power Hybrid (HPH) Resistance Screening System and corresponding 100% inspection process. |
| P110042/S019 11/26/13 |
Subcutaneous Implantable Defibrillator (S-ICD) System | Cameron Health, Inc. Clemente, CA 92673 |
Insourcing of the Q-GUIDE Electrode Insertion Tool. |
| P120008/S004 11/26/13 |
ARCHITECT AFP | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Replacement of a quality control test with a new quality control test for an incoming raw material. |
| P120008/S005 11/26/13 |
ARCHITECT AFP | Abbott Laboratories, Diagnostics Abbott Park, IL 60064 |
Addition of a quality control test method for incoming lots of Triton X-100. |
