Summary of PMA Originals & Supplements Approved
- Originals: 2
- Supplements: 67
Summary of PMA Originals Under Review
- Total Under Review: 55
- Total Active: 26
- Total On Hold: 29
Summary of PMA Supplements Under Review
- Total Under Review: 543
- Total Active: 422
- Total On Hold: 121
Summary of All PMA Submissions
- Originals: 3
- Supplements: 80
Summary of PMA Supplement PMA Approval/Denial Decision Times
- Number of Approvals: 67
- Number of Denials: 0
- Average Days Fr Receipt to Decision (Total Time): 88.6
- FDA Time: 81.6 Days
- MFR Time: 7.0 Days
November 2014 PMA Approvals
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P120011 11/14/14 |
IDEAL IMPLANT® Saline-Filled Breast Implant | Ideal Implant Incorporated Dallas, TX 75244 |
Approval for the IDEAL IMPLANT Saline-filled Breast Implant. This device is indicated for women at least 18 years old undergoing: 1) Primary breast augmentation to increase breast size; and 2) Revision breast augmentation to correct or improve the result of a primary breast augmentation surgery. |
P130007 11/25/14 |
Animas Vibe System | ANIMAS Corporayion West Chester, PA 19380 |
Approval for the Animas Vibe System. This device is indicated for: The Animas® Vibe™ System consists of the Animas® Vibe™ Insulin Pump paired with the Dexcom G4 PLATINUM Sensor and Transmitter. The Animas® Vibe™ Insulin Pump is indicated for continuous subcutaneous insulin infusion for the management of insulin-requiring diabetes. It can be used solely for continuous insulin delivery and as part of the Animas® Vibe™ System to receive and display continuous glucose measurements from the Dexcom G4 PLATINUM Sensor and Transmitter. The Animas® Vibe™ System’s continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of results from the Dexcom G4 PLATINUM Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time. The System is intended for single patient use and requires a prescription. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P870076/S014 11/17/14 Special |
Falope-Ring Band and Applicator Systems | Gyrus ACMI, Inc. Southborough, MA 01772 |
Approval for labeling clarifications regarding not loading devices more than thirty minutes before use, and reducing languages in device labeling to only English and French. |
P890003/S319 11/7/14 Real-Time |
Medtronic CareLink, Remote Home Monitor, CareLink Express Monitor |
Medtronic Inc. Mounds View, MN 55112 |
Approval for an update to the CareLink and CareLink Express Monitor firmware and software to improve the superimposed dual EGM reporting. |
P890003/S320 11/7/14 Real-Time |
MyCareLink Patient Monitor | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Software version R67 of MyCareLink Patient Monitor 24950 to be used with the devices. |
P890023/S022 11/21/14 180-Day |
Ocufilcon D soft (hydrophilic) extended wear contact lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Approval for the addition of the new private label brand name EQUATE asphere and EQUATE toric to the device labeling. |
P910023/S343 11/20/14 Real-Time |
Fortify, Fortify Assura Family of ICDs | St. Jude Medical Slymar, CA 91342 |
Approval for design modifications to the battery header in the batteries utilized in the devices. |
P910073/S128 11/4/14 180-Day |
Acuity X4 Connector Tool | Boston Scientific Corp. St. Paul, MN 55112 |
Approval for the Acuity X4 Connector Tool Model 4625 accessory. |
P910077/S147 11/6/14 Real-Time |
VENTAK PRX AND VENTAK MINI-Latitude Consult System | Boston Scientific Corp. St. Paul, MN 55112 |
Approval for the LATITUDE Consult System Release 1.01 which includes the Communicator Model 6299 and Application Software Server Model 6294. |
P950005/S054 11/18/14 Real-Time |
Celsius Flutters, Celsius, Celsius RMT, EZ Steer 4mm Non-Nav, EZ Steer DS |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the solder in order to comply with the EU RoHS Directive. |
P950008/S012 11/3/14 180-Day |
Silikon 1000 | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for a manufacturing site located at Alcon Research, Ltd., in Fort Worth, Texas. |
P950029/S098 11/7/14 180-Day |
Reply SR, DR, Esprit SR, DR |
Sorin CRM USA, Inc. Arvada, CO 80004 |
Approval for a manufacturing site located at Sterigenics Petit-Rechain in Verviers, Belgium. |
P950037/S137 11/17/14 180-Day |
Etrinsa 8/6 Dr-t/sr-t, Etrinsa 6 Dr/sr, Epyra 8/6 Dr-t/sr-t, Eluna 8 Dr-t/sr-t, Dr/sr, Pro Mri Pacemakers | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Etrinsa, Epyra and Eluna Pacemaker families with Programmer Software 1304.U for the Renamic Programmer and Home Monitoring Service Center with Software Version 3.26.0. |
P950039/S031 11/20/14 Real-Time |
ThinPrep® Processors | Hologic, Inc. Marlborough, MA 01752 |
Approval for reformulation of tubing that delivers air and processing reagents to the patient’s sample, a change to the pump used on the ThinPrep® 3000 (TP3000) and modification of the T-2000 Head Lever Assembly to reduce tolerance stack-up. |
P960016/S049 11/6/14 Real-Time |
Livewire TC and Safire Bidirectional Ablation Catheters | St. Jude Medical St. Paul, MN 55117 |
Approval for a minor design change to the solder for the approved Livewire TC and Safire Bidirectional Ablation Catheters. |
P960040/S332 11/7/14 Real-Time |
NG3 Implantable Cardioverter Defibrillator (ICD) DYNAGEN™ EL ICD, INOGEN™ EL ICD, ORIGEN™ EL ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the battery feedthru modifications of the devices. |
P970053/S013 11/21/14 180-Day |
Nidek EC-5000 Excimer Laser System | Nidek Co., Ltd. Gamagori, Aichi Japan 443-0038 |
Approval to use the OPD-Scan III aberrometer and update the Final Fit software (v1.11 to 1.12) to facilitate compatibility with a new aberrometer to perform topography-guided laser in-situ keratomileusis (LASIK). |
P970053/S014 11/14/14 Real-Time |
Nidek EC-5000 Excimer Laser | Nidek Co., Ltd. Gamagori, Aichi Japan 443-0038 |
Approval for a new 200 Hz eyetracker, which replaces the existing 200 Hz eyetracker used with the EC-5000 Excimer Laser. This change also includes modification to the associated camera and software as well as the IR illumination. |
P980016/S500 11/7/14 Real-Time |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD 7287, Intrinsic ICD 7288, Marquis DR ICD 7274, Marquis VR ICD 7230, Maximo DR ICD 7278, Maximo II ICD, Maximo VR ICD 7232, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Software version R67 of MyCareLink Patient Monitor 24950 to be used with the devices. |
P980016/S502 11/14/14 180-Day |
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 |
Approval for the design and manufacturing changes of the 9-Pin Feedthrough subassembly in the PMA supplements. |
P980035/S391 11/7/14 Real-Time |
Adapta, Versa, Sensia, Enpulse E1/E2, Kappa D/DR/VDD IPGs | Medtronic Inc. Mounds View, MN 55112 |
Approval for an update to the CareLink and CareLink Express Monitor firmware and software to improve the superimposed dual EGM reporting. |
P980035/S392 11/7/14 Real-Time |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, EnPulse E1 IPG, EnPulse E2 IPG, Kappa D, IPG Kappa, Kappa DR IPG, Kappa DR IPG, Kappa DR IPG, Kappa SR IPG, Kappa VDD IPG |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Software version R67 of MyCareLink Patient Monitor 24950 to be used with the devices. |
P980049/S099 11/4/14 180-Day |
INTENSIA CRT-D | Sorin CRM USA, Inc. Arvada, CO 80004 |
Approval for the INTENSIA ICD and CRT-D devices. |
P980049/S102 11/6/14 Real-Time |
Paradym RF VR, Paradym RF DR ICDs Software for SmartView Monitor | Sorin Group Arvada, CO 80004 |
Approval for a change to the software code for the SmartView (Home) Monitor used for the devices. |
P980049/S103 11/7/14 180-Day |
Paradym VR and DR, Paradym RF SR and DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Approval for a manufacturing site located at Sterigenics Petit-Rechain in Verviers, Belgium. |
P990025/S042 11/19/14 Real-Time |
NaviStar 4mm, NaviStar RMT 4mm, EZ Steer 4mm Nav | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the solder in order to comply with the EU RoHS Directive. |
P990040/S019 11/5/14 Real-Time |
TRUFILL® n-BCA (N-Butyl Cyanoacrylate) Liquid Embolic System | Codman & Shurtleff Raynham, MA 02767 |
Approval to replace the current sterile pouch for the TRUFILL® n-BCA and the Tantalum Powder components with a new sterile pouch of the same materials as the existing pouch with a new pouch coating and new thumb notches and is sourced from a new vendor, Oliver-Tolas Healthcare Products. |
P990071/S029 11/19/14 Real-Time |
CoolFlow Irrigation Pump | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to solder composition required for EU RoHS compliance. |
P990074/S030 11/4/14 Real-Time |
Natrelle Saline-Filled Breast Implants | Allergan Goleta, CA 93117 |
Approval for an alternate material for one component used in the fill tube for Natrelle Saline-Filled Breast Implants. |
P990075/S029 11/26/14 Real-Time |
Mentor Saline-Filled and Spectrum Breast Implant | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Approval for modifications to the Winged Infusion Set Accessory of the Mentor Saline-Filled and Spectrum Breast Implant. The modifications included: 1. Texture, beveled edges, and a finger hole was added to each (2) side of the wing design; 2. Phthalate was eliminated from the wing material: PVC Nakan FEM 828 N N with DEHP with Colorant Masterbatch PVC 9154 Green to PVC Nakan FEM 828 N N with DEHT with Colorant Masterbatch PVC 9154 Green; and 3. Phthalate was eliminated from the tubing material: PVC Nakan FMA 748 N N with DEHP to PVC Nakan FMA 748 N N with DEHT. |
P000006/S038 11/4/14 Special |
Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Approval for labeling changes to strengthen existing instructions on pump filling and activation. |
P000008/S032 11/5/14 Special |
LAP-BAND® Adjustable Gastric Banding System | Apollo Endosurgery, Inc. Austin, TX 78746 |
Approval for labeling modifications to 1) add identifiers to a picture of a calibration tube; and (2) add a note that the user should not overinflate the balloon. |
P000009/S058 11/17/14 180-Day |
Etrinsa, Epyra and Eluna Pacemaker families ICD’S | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Etrinsa, Epyra and Eluna Pacemaker families with Programmer Software 1304.U for the Renamic Programmer and Home Monitoring Service Center with Software Version 3.26.0. |
P010012/S371 11/7/14 Real-Time |
NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT-D), DYNAGEN ™ CRT-D, DYNAGEN ™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, ORIGEN™ CRT-D, ORIGEN™ X4 CRT-D | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the battery feedthru modifications of the devices. |
P010015/S248 11/7/14 Real-Time |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Software version R67 of MyCareLink Patient Monitor 24950 to be used with the devices. |
P010031/S464 11/7/14 Real-Time |
Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD 7295, InSync III Marquis ICD 7279, InSync Maximo ICD 7304, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Software version R67 of MyCareLink Patient Monitor 24950 to be used with the devices. |
P010031/S466 11/14/14 180-Day |
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 |
Approval for the design and manufacturing changes of the 9-Pin Feedthrough subassembly in the PMA supplements. |
P010050/S016 11/18/14 135-Day |
IMMULITE® HBsAg Kit and IMMULITE® 2000 HBsAg Kit | Siemens Healthcare Diagnostics East Walpole, MA 02032 |
Approval for a change in the material used to establish the lot-specific factor that is incorporated in the calculation of the assay cutoff. |
P010068/S043 11/18/14 Real-Time |
NaviStar DS, Celsius DS, EZ Steer Nav DS, NaviStar RMT DS, Celsius Flutters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the solder in order to comply with the EU RoHS Directive. |
P030031/S062 11/18/14 Real-Time |
NaviStar ThermoCool, Celsius ThermoCool, NaviStar RMT, ThermoCool, EZ Steer ThermoCool, Celsius RMT ThermoCool, ThermoCool SF, ThermoCool ST | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the solder in order to comply with the EU RoHS Directive. |
P030031/S063 11/19/14 Special |
ThermoCool SmartTouch Catheter for Treatment of Type I Atrial Flutter and Atrial Fibrillation | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for minor labeling changes-additional contraindications and warning |
P030054/S274 11/20/14 Real-Time |
Quadra Assure, Unify, Unify Assura, Unify Quadra Family of CRT-Ds | St. Jude Medical Slymar, CA 91342 |
Approval for design modifications to the battery header in the batteries utilized in the devices. |
P040024/S070 11/14/14 180-Day |
Restylane, Restylane-L, Perlane and Perlane-L | Galderma Laboratories, L.P. Fort Worth, TX 76177 |
Approval for new supplier of raw Hyaluronic Acid (i.e., HTL Biotechnology S.A.S., France). |
P040036/S046 11/18/14 Real-time |
NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool, ThermoCool ST | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for changes to the solder in order to comply with the EU RoHS Directive. |
P040036/S047 11/19/14 Special |
ThermoCool SmartTouch Catheter for Treatment of Ventricular Tachycardia |
Biosense Webster, Inc. Diamond Bar, California 91765 |
Approval for minor labeling changes.additional contraindications and warning |
P040046/S008 11/7/14 Real-Time |
Natrelle 410 Highly Cohesive Anatomically Shaped Breast Implant | Allergan Goleta, CA 93117 |
Approval for additional Natrelle 410 device styles and sizes including: One (1) size of Style FL 410; One (1) size of Style ML 410; Two (2) sizes of Style LL 410; Four (4) sizes of Style LM 410; Ten (10) sizes of Style LF 410; Nine (9) sizes of Style FX 410; Nine (9) sizes of Style MX 410; and Seven (7) sizes of Style LX 410. |
P050023/S077 11/17/14 180-Day |
LUMAX 300/340 & 500/540 DR/DR-T/VR/VR-T ICD’S, LUMAX 540 VR-T DX ICD, KRONOS LV-T, LUMAX 300/340 & 500/540 HF/HF-T CRT-D, Etrinsa, Epyra and Eluna Pacemaker families with programmer | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Etrinsa, Epyra and Eluna Pacemaker families with Programmer Software 1304.U for the Renamic Programmer and Home Monitoring Service Center with Software Version 3.26.0. |
P050047/S042 11/19/14 Special |
JUVÉDERM Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Approval for the strengthening of the current warning and the discussion of the potential adverse reaction(s) associated with vascular injection. |
P060019/S029 11/6/14 Real-Time |
The Cool Point Irrigation Pump | St. Jude Medical Irvine, CA 92614 |
Approval to implement a minor design modification to the Cool Point Irrigation Pump to include a pump pressure alarm adapter and a pressure alarm adapter cable. |
P060027/S066 11/4/14 180-Day |
INTENSIA ICD Devices | Sorin CRM USA, Inc. Arvada, CO 80004 |
Approval for the INTENSIA ICD and CRT-D devices. |
P060027/S069 11/6/14 Real-Time |
Paradym RF CRT-D Software for SmartView Monitor |
Sorin Group Arvada, CO 80004 |
Approval for a change to the software code for the SmartView (Home) Monitor used for the devices. |
P060027/S070 11/7/14 180-Day |
Paradym CRT-D, RF CRT-D | Sorin CRM USA, Inc. Arvada, CO 80004 |
Approval for a manufacturing site located at Sterigenics Petit-Rechain in Verviers, Belgium. |
P060038/S021 11/25/14 180-Day |
MitroFlow Aortic Pericardial Heart Valve (MAPHV™) | Sorin Group USA, Inc. Burnaby BC, Canada V5J 5M1 |
Approval of the post-approval study protocol. |
P070008/S053 11/17/14 180-Day |
Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF Pacemaker/ICD/CRT Non-Implanted Components Programmer Software for the ICS 3000/ Renamic Programmers, Pacemaker/ICD/ CRT Non-Implanted Components Programmer Software for the ICS 3000/Renamic Programmers |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Etrinsa, Epyra and Eluna Pacemaker families with Programmer Software 1304.U for the Renamic Programmer and Home Monitoring Service Center with Software Version 3.26.0. |
P080009/S003 11/3/14 180-Day |
Sedasys Computer-Assisted Personalized Sedation System | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 |
Approval of the post-approval study protocol. |
P090012/S077 11/26/14 135-Day |
MelaFind | MELA Sciences Incorporated Irvington, NY 10533 |
Approval for the changes listed below: 1) Initial release of USB 2.0 for Hand-held Imager; 2) Redesigned Card Reader Assembly; 3) Released Accessory Kit with digital camera; 4) High capacity card option added; and 5) Modified Phantom Fixture mechanical tolerances. |
P090013/S154 11/7/14 Real-Time |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Software version R67 of MyCareLink Patient Monitor 24950 to be used with the devices. |
P100018/S013 11/4/14 Special |
Pipeline™ Embolization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Irvine, CA 92618 |
Approval for the modification of safety information in the labeling. |
P100031/S012 11/26/14 Real-Time |
Elecsys ® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc | Roche Diagnostics Indianapolis, IN 46250 |
Approval for software updates of the US specific e-barcode for the cobas e 601 and the US specific assay barcode transfer sheet for the Modular Analytics E170 to implement the grey-zone. |
P100034/S007 11/12/14 180-Day |
NovoTTF-100A System | NovoCure, Ltd. Haifi, Israel 31905 |
Approval for changes to the NovoTTF-100A Insulated Electrode (INE) transducer array manufacturing process to improve its efficiency by automating certain manual processing steps. |
P110006/S004 11/24/14 Real-Time |
Invenia ABUS Automated Breast Ultrasound | U-Systems, Inc. Sunnyvale, CA 94085 |
Approval of a change in the device design to accommodate a new device configuration. The new device configuration consists of the following components: Invenia ABUS Scan Station, Invenia ABUS Review Software, and user computer/ work station that is qualified to meet a required set of hardware and software specification. In addition to the proposed additional device configuration, the supplement requested approval of minor software updates to address issues discovered through internal testing and customer feedback. These changes include marker positioning on images, DICOM-related image content, and general image formatting, processing, and transfer. The supplement also requested labeling changes associated with the above-specified device change, specifically in Workstation User Manual, System Setup and Basic Service Manual, and Scan Station Manual. |
P110013/S042 11/19/14 135-Day |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval to modify the drug spray coating process. |
P110022/S013 11/26/14 Real-Time |
Elecsys ® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM | Roche Diagnostics Indianapolis, IN 46250 |
Approval for software updates of the US specific e-barcode for the cobas e 601 and the US specific assay barcode transfer sheet for the Modular Analytics E170 to implement the grey-zone. |
P110025/S011 11/26/14 Real-Time |
Elecsys ® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM | Roche Diagnostics Indianapolis, IN 46250 |
Approval for software updates of the US specific e-barcode for the cobas e 601 and the US specific assay barcode transfer sheet for the Modular Analytics E170 to implement the grey-zone. |
P110033/S012 11/19/14 Special |
JUVÉDERM VOLUMA XC | Allergan Goleta, CA 93117 |
Approval for the addition of a precaution regarding compliance with needle attachment instructions. |
P120016/S004 11/6/14 Real-Time |
Vascade Vascular Closure System | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Approval for a change to the joint of the support and core tubes. |
P120020/S003 11/7/14 180-Day |
Supera Peripheral Stent System | Abbott Vascular Inc. Santa Clara, CA 92054 |
Approval for a change to the colors included in the 6Fr and 7Fr delivery systems manufactured at the current site in Webster, Texas. |
P130015/S002 11/26/14 Real-Time |
Elecsys ® HBeAg Immunoassay and Elecsys® PreciControl HBeAg | Roche Diagnostics Indianapolis, IN 46250 |
Approval for software updates of the US specific e-barcode for the cobas e 601 and the US specific assay barcode transfer sheet for the Modular Analytics E170 to implement the grey-zone. |
P130016/S005 11/12/14 180-Day |
Nucleus Hybrid L24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for CP900 series Sound Processor firmware features as part of the Nucleus Hybrid L24 Cochlear Implant system. These features include a Wind Noise Reduction (WNR) algorithm, a Signal-to-Noise Ratio-Based Noise Reduction (SNR-NR) function, and an Automatic Environmental Classifier (SCAN) function. |
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 |
---|---|---|---|
N18286/S027 11/4/14 |
GELFOAM (absorbable gelatin) Sterile Sponge | Pfizer, Inc. New York, NY 10017 |
Proposed addition of an alternate production area for Gelfoam Bulk Solution Manufacturing. |
P790007/S044 11/12/14 |
Hancock Modified Orifice Valved Conduit | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of two new porcine tissue suppliers. |
P810006/S057 11/18/14 |
CollaStat Absorbable Collagen Hemostatic Sponge CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar Form |
Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Updating the operational parameters of a sealing machine used in the Collagen Area at Integra NeuroSciences facility in Anasco, Puerto Rico for the devices. |
P860004/S216 11/17/14 |
Medtronic SynchroMed Infusion System | Medtronic, Incorporated Minneapolis, MN 55432 |
Move of a supplier manufacturing line. |
P860057/S129 11/14/14 |
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprosthesis | Edwards Lifesciences, LLC. Irvine, CA 92614 |
New enclosure and equipment to be used in the particulate evaluation process of components. |
P870078/S028 11/12/14 |
Hancock Low Porosity Valved Conduit | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of two new porcine tissue suppliers. |
P880086/S250 11/21/14 |
Assurity PM1240, PM2240; Assurity + PM1260, PM2260; Endurity PM1160, PM2160 | St. Jude Medical Sylmar, CA 91342 |
Use of a reflow oven to cure epoxy on the hybrid and RF module assemblies. |
P910023/S347 11/21/14 |
Ellipse DR, Ellipse VR, Current DR, Current DR RF, Current Accel DR, Current+ DR, Current VR, Current VR RF, Current Accel VR, Current+ VR, Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR |
St. Jude Medical Sylmar, CA 91342 |
Use of a reflow oven to cure epoxy on the hybrid and RF module assemblies. |
P950037/S143 11/6/14 |
Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (Dextrus, Setrox, TILDA, Safio) |
Biotronik, Inc. Lake Oswego, OR 97035 |
Use of an automated process to measure the retracted and extended lengths and electrical resistance of the fixation helix used in the leads. |
P950037/S144 11/21/14 |
Ecuro DR 375437, Epyra 6 DR-T 394932, Ecuro DR-T 375439, Epyra 6 SR-T 394937, Ecuro SR 375433, Epyra 8 DR-T 394930, Ecuro SR-T 375435, Epyra 8 SR-T 394935, Effecta D 375429, Estella DR 371205, Effecta DR 371199, Estella DR-T 371207, Effecta S 375431, Estella SR 371209, Effecta SR 371202, Estella SR-T 371200, Eluna 8 DR-T ProMRI 394969, Etrinsa 6 DR 394928, Eluna 8 DR ProMRI 394970, Etrinsa 6 DR-T 394933, Eluna 8 SR-T ProMRI 394971, Etrinsa 6 SR-T 394938, Eluna 8 SR ProMRI 394972, Etrinsa 6 SR 394940, Entovis DR 365461, Etrinsa 8 DR-T 394931, Entovis DR 371991, Etrinsa 8 SR-T 394936, Entovis DR-T 365463, Evia DR 359524, Entovis DR-T 371992, Evia DR-T 359529, Entovis SR 365465, Evia SR 359531, Entovis SR 371993, Evia SR-T 359533, Entovis SR-T 365467, Entovis SR-T 371994 | Biotronik, Inc. Lake Oswego, OR 97035 |
Changes to equipment used in the production of IS-1 connector ports. |
P960009/S210 11/21/14 |
Activa Deep Brain Stimulation (DBS) Therapy System, DBS Leads, | Medtronic, Inc. Minneapolis, MN 55432 |
Addition of new inspection equipment. |
N970003/S168 11/17/14 |
ADVANTIO Pacemaker, INGENIO Pacemaker, VITALIO Pacemaker, FORMIO Pacemaker | Boston Scientific Corporation St. Paul, MN 55112 |
Modify the crystal oscillator manufacturing process at an existing supplier for the devices. |
N970012/S100 11/6/14 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 |
Implementation of two duplicate convection ovens. |
N970012/S101 11/18/14 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka, MN 55343 |
Implementation of an additional tray sealer. |
P970031/S048 11/12/14 |
Freestyle Aortic Root Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of two new porcine tissue suppliers. |
P980022/S162 11/21/14 |
Continuous Glucose Monitoring System | Medtronic MiniMed Northridge, CA 91325 |
Changes to the fabrication process for the Sof-sensor (MMT-7002). The Sof-sensor is a component of the Continuous Glucose Monitoring System, Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian Real Time CGM System, MiniLink REAL-Time System, iPro Recorder CGM System, and iPro 2 Professional CGM System. |
P980022/S163 11/19/14 |
Paradigm REAL-Time System Paradigm REAL-Time Revel System |
Medtronic, Inc. Northridge, CA 91325 |
Addition of equipment used in the manufacture of the Paradigm REAL-Time, Paradigm REAL-Time Revel, and MiniMed 530G Insulin Pumps that are part of the Paradigm REAL-Time System, the Paradigm REAL-Time Revel System, and the MiniMed 530G System. |
P980022/S165 11/26/14 |
Paradigm® REAL-Time System and Paradigm® REAL-Time Revel System | Medtronic, Inc. Northridge, CA 91325 |
Change from a manual process to a semi-automated process for a test carried out during acceptance testing of 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); MiniMed 530G Insulin Pump (Models: MMT-551, MMT-751) cases. The Paradigm® REAL-Time, Paradigm® REAL-Time Revel, and Minimed 530G insulin pumps are components of the Paradigm® REAL-Time System, Paradigm® REAL-Time Revel System, and Minimed 530G System, respectively. |
P980022/S169 11/26/14 |
Paradigm Real-Time Revel System | Medtronic MiniMed Northridge, CA 91325 |
Change to the mold used in the manufacturing of the USB connector, a component in the mySentry Monitor that is used to receive data from the Paradigm Real-Time Revel System. |
P980040/S051 11/12/14 |
TECNIS® and TECNIS® Multifocal 1-Piece IOL with the TECNIS iTec Preloaded Delivery System | Abbott Medical Optics, Inc. Santa Anna, CA 92705 |
Adding an alternate molding supplier for the cartridge component used in the TECNIS iTec Preload Delivery System. |
P980040/S052 11/21/14 |
TECNIS, SENSAR | Abbott Medical Optics, Inc. Santa Anna, CA 92705 |
Addition of a new purified water system and a new air-handling unit system. |
P980040/S053 11/15/14 |
SENSAR® 1-piece Intraocular Lens | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Change from machined to a molded IOL edge blocker, change in cycle time for the IOL tumbling process, addition of a cosmetic inspection following sterilization, change in test method used to determine bacterial endotoxin levels of IOLS, and new ultra high performance liquid chromatography equipment for testing residual monomer levels of IOL soft acrylic material. |
P980043/S050 11/12/14 |
Hancock II Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of two new porcine tissue suppliers. |
P990046/S039 11/13/14 |
Open Pivot Heart Valve and Open Pivot Aortic Valved Graft | Medtronic, Inc. Minneapolis, MN 55432 |
Upgrade to a current component software application. |
P990064/S059 11/12/14 |
Mosaic Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Addition of two new porcine tissue suppliers. |
P990075/S028 11/19/14 |
Mentor SPECTRUM and Saline-Filled Breast Implants | Mentor Worldwide LLC Santa Barbara, CA 93111 |
Change to add an alternate supplier for Isopropyl Alcohol (IPA) used in the production of Spectrum and Saline-filled Breast Implants at Mentor’s Irving, Texas Facility. |
P000040/S034 11/25/14 |
Genesys HTA System | Boston Scientific Corporation Marlborough, MA 01752 |
Removal of the in-process burst test for the Sheath Assembly Tray. |
P000053/S052 11/18/14 |
AMS 800 Urinary Control System | American Medical Systems, Inc. Minnetonka, MN 55343 |
Implementation of an additional tray sealer. |
P010013/S061 11/14/14 |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Update and correction on instruction and packaging procedures. |
P010014/S049 11/13/14 |
Oxford Partial Knee System | Biomet, Incorporated Warsaw, IN 46582 |
Addition of new manufacturing equipment. |
P010020/S028 11/18/14 |
AMS Acticon Neosphincter Artificial Bowel Sphincter | American Medical Systems, Inc. Minnetonka, MN 55343 |
Implementation of an additional tray sealer. |
P010030/S057 11/19/14 |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Alternate component suppliers for the battery charger power supply and the stainless steel electrode layer. |
P010032/S086 11/13/14 |
Eon Mini Implantable Pulse Generator, Protégé Implantable Pulse Generator, Protégé MRI Implantable Pulse Generators | St. Jude Medical Plano, TX 75024 |
Implement manufacturing process changes. |
P030005/S114 11/17/14 |
INVIVE, INTUA | Boston Scientific Corporation St. Paul, MN 55112 |
Modify the crystal oscillator manufacturing process at an existing supplier for the devices. |
P030017/S207 11/14/14 |
Precision® and Precision Spectra™ Spinal Cord Stimulator (SCS) Systems; Infinion 1×16 Percutaneous Lead Continuity Test Fixture |
Boston Scientific Corporation Valencia, CA 91355 |
Device test fixture modification. |
P030017/S208 11/25/14 |
Precision Spectra Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Valencia, CA 91355 |
Alternate bonding method used during the manufacture of the telemetry coil, an electronic component on the Printed Circuit Board Assembly (PCBA) of the Precision Spectra (IPG). |
P030035/S128 11/21/14 |
Allure PM3120: Allure Quadra PM3140; Allure RF PM3222; Allure Quadra RF PM3242; Accent DR PM2110; Accent DR RF PM2210; Accent SR PM1110; Accent SR RF PM1210; Anthem PM3110; Anthem RF PM3210 |
St. Jude Medical Sylmar, CA 91342 |
Use of a reflow oven to cure epoxy on the hybrid and RF module assemblies. |
P030054/S277 11/21/14 |
Promote, Promote Accel, Promote RF, Promote Q, Promote Quadra, Promote+, Quadra Assura, Unify, Unify Assura, Unify Quadra |
St. Jude Medical Sylmar, CA 91342 |
Use of a reflow oven to cure epoxy on the hybrid and RF module assemblies. |
P040024/S078 11/21/14 |
Restylane, Restylane-L Perlane, and Perlane-L Injectable Gels | Galderma Laboratories, L.P. Fort Worth, TX 76177 |
Expansion of cleanroom F1 at the QMed facility in Uppsala, Sweden. |
P040037/S076 11/21/14 |
Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. Flagstaff, AZ 86005 |
Modifications to the stripping machine used during removal of graft components from the process mandrel. |
P040044/S058 11/25/14 |
MynxGrip Vascular Closure Device | Access Closure, Inc. Santa Clara, CA 954054 |
Replacing the manual application of adhesive in the pusher lock assembly process with a more automated system. |
P040047/S037 11/12/14 |
Coaptite Injectable Implant | Merz North America, Inc. Franksville, WI 53126 |
Relocation of the Quality Incoming Inspection Lab, the installation of the QC Clean Room, and the installation of an automated temperature/ humidity monitoring system. |
P050023/S082 11/21/14 |
Iforia 5 HF-T (DF4) 383553, Ilesto 7 HF-T (GB) 383547, Iforia 7 HF-T (DF4, Li) 390057, Ilesto 7 HF-T (Litronik 383546, Iforia 7 HF-T (DF4, GB) 390060, Ilesto 7 HF-T (DF4, Litronik) 383548, Ilesto 5 HF-T 383550, Ilesto 7 HF-T (DF4, GB) 383549, Ilesto 5 HF-T (DF4) 383552 | Biotronik, Inc. Lake Oswego, OR 97035 |
Changes to equipment used in the production of IS-1 connector ports. |
P070008/S058 11/21/14 |
Eluna 8 HF-T 394917, Etrinsa 8 HF-T 394919, Entovis HF 377187, Evia HF 377206, Entovis HF-T 377193, Evia HF-T 377208, Epyra 8 HF-T 394918 | Biotronik, Inc. Lake Oswego, OR 97035 |
Changes to equipment used in the production of IS-1 connector ports. |
P080026/S012 11/20/14 |
Abbott RealTime HBV Assay | Abbott Molecular Des Plaines, IL 60018 |
Change to add a single, automated bottling line for component filling and capping. |
P100017/S010 11/20/14 |
Abbott RealTime HCV Assay | Abbott Molecular Des Plaines, IL 60018 |
Change to add a single, automated bottling line for component filling and capping. |
P100021/S042 11/25/14 |
Endurant IIs Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Addition of an alternate supplier for the secondary and tertiary packaging for Endurant IIs Stent Graft Systems, as well as a change in configuration for the E-beam sterilization process. |
P100023/S109 11/5/14 |
Ion Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change the bonding process parameters used to create the bi-component subassembly. |
P100041/S060 11/14/14 |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC. Irvine, CA 92614 |
New enclosure and equipment to be used in the particulate evaluation process of components. |
P100041/S061 11/25/14 |
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Expansion of the current manufacturing clean room environment used to manufacture the transcatheter heart valve accessories at the Edwards Draper, Utah facility. |
P110010/S098 11/5/14 |
PROMUS Element™ Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change the bonding process parameters used to create the bi-component subassembly. |
P110021/S047 11/14/14 |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, LLC. Irvine, CA 92614 |
New enclosure and equipment to be used in the particulate evaluation process of components. |
P110021/S048 11/25/14 |
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Expansion of the current manufacturing clean room environment used to manufacture the transcatheter heart valve accessories at the Edwards Draper, Utah facility. |
P110042/S042 11/25/14 |
Cameron Health Subcutaneous Implantable Defibrillator S-ICD System | Boston Scientific St. Paul, MN 55112 |
To disposition non-conforming feedthrus at receiving inspection. |
P120005/S029 11/26/14 |
Dexcom G4 Platinum Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Change in the solder mask pattern of the Radio Frequency Transceiver, which is a component of the G4 Platinum Continuous Glucose Monitoring System. |
P120006/S016 11/20/14 |
Ovation and Ovation Prime Abdominal Stent Graft Systems | TriVascular, Inc. Santa Rosa, CA 95403 |
Modified and new tools for use in the process for loading the stent grafts into the delivery system sheaths. |
P120010/S037 11/19/14 |
MiniMed 530G System | Medtronic, Inc. Northridge, CA 91325 |
Addition of equipment used in the manufacture of the Paradigm REAL-Time, Paradigm REAL-Time Revel, and MiniMed 530G Insulin Pumps that are part of the Paradigm REAL-Time System, the Paradigm REAL-Time Revel System, and the MiniMed 530G System. |
P120010/S038 11/21/14 |
MiniMed 530G System | Medtronic MiniMed Northridge, CA 91325 |
Change in the sensor assembly manufacturing process and an alternate supplier for the needle hub assembly. |
P120010/S039 11/20/14 |
Minimed 530G System | Abbott Molecular Des Plaines, IL 60018 |
Change to add a single, automated bottling line for component filling and capping. |
P120012/S005 11/20/14 |
Abbott RealTime HCV Genotype II Assay | Abbott Molecular Des Plaines, IL 60018 |
Manufacturing process change to add a single, automated bottling line for component filling and capping. |
P120016/S007 11/17/14 |
VASCADE™ Vascular Closure System (VCS) | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Semi-automation of the collagen compression process. |
P130006/S015 11/21/14 |
Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. 86005 |
Modifications to the stripping machine used during removal of graft components from the process mandrel. |
P130008/S004 11/6/14 |
Inspire II Implantable Pulse Generator (IPG) | Inspire Medical Systems, Inc. Maple Grove, MN 55369 |
Install a new cure and preheat oven at the contract manufacturer’s Medtronic Puerto Rico Operations Company (MPROC) location. |
P130009/S015 11/14/14 |
Edwards SAPIEN XT Transcatheter Heart Valve | Edwards Lifesciences, LLC. Irvine, CA 92614 |
New enclosure and equipment to be used in the particulate evaluation process of components. |
P130009/S018 11/25/14 |
Edwards SAPIEN XT™ Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Expansion of the current manufacturing clean room environment used to manufacture the transcatheter heart valve accessories at the Edwards Draper, Utah facility. |