Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 101
Summary of PMA Originals Under Review
Total Under Review: 51
Total Active: 26
Total On Hold: 25
Summary of PMA Supplements Under Review
Total Under Review: 513
Total Active: 373
Total On Hold: 140
Summary of All PMA Submissions Received
Originals: 3
Supplements: 78
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 101
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 131.9
FDA Time: 103.2 Days MFR Time: 28.7 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P100045 5/28/14 |
CardioMEMS™ HF System | CardioMEMS, Inc. Atlanta, GA 30313 |
Approval for the CardioMEMS™ HF System, which includes the CM2000 implantable PA Sensor/Monitor and transvenous catheter delivery system, the CM1000 Patient Electronics System (GSM), the CM1010 Patient Electronics System (GSM), and CM3000 Hospital Electronics System. This device is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations. |
| P110005 5/9/14 |
Gel-Syn™ | IBSA Institut Biochimique SA Thousand Oaks, CA 91320 |
Approval for Gel-Syn™. This device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g. acetaminophen). |
| P110027 5/23/14 |
therascreen® KRAS RGQ PCR Kit | QIAGEN Manchester, UK M15 6SH |
Approval for the therascreen® KRAS RGQ PCR Kit, which is to be used as a companion diagnostic for the drug Vectibix® (panitumumab). This device is indicated for: The therascreen® KRAS RGQ PCR Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene, using DNA extracted from formalin-fixed paraffin-embedded (FFPE), colorectal cancer (CRC) tissue. The therascreen® KRAS RGQ PCR Kit is intended to aid in the identification of CRC patients for treatment with Erbitux® (cetuximab) and Vectibix® (panitumumab) based on a KRAS no mutation detected test result. |
| P110041 5/16/14 |
ADVIA Centaur® HBsAgII (HBsII), ADVIA Centaur® HBsAg Confirmatory, ADVIA Centaur® HBsAg Quality Control Material |
Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for the ADVIA Centaur HBsAgII, ADVIA Centaur HBsAg Confirmatory, and ADVIA Centaur HBsAg Quality Control Material. This device is indicated for: ADVIA Centaur HBsAgII (HBsII) – The ADVIA Centaur HBsAgII (HBsII) assay is an in vitro immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult, adolescent, and pediatric serum and plasma (EDT A, lithium-heparin, or sodium-heparin), and neonatal samples using the ADVIA Centaur and ADVIA Centaur XP systems. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infection. The assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. ADVIA Centaur HBsAg Confirmatory The ADVIA Centaur HBsAg Confirmatory assay is an in vitro immunoassay for the confirmation of hepatitis B surface antigen (HBsAg) in human serum and plasma (potassium EDTA, lithium-heparin, or sodium-heparin), and neonatal samples using the ADVIA Centaur and ADVIA Centaur XP systems. The assay is intended to be used to confirm the presence of HBsAg in samples that are repeatedly reactive using the ADVIA Centaur HBsAgII assay. ADVIA Centaur HBsAg Quality Control Material For monitoring the performance of the HBsAg, HBsAgII and HBsAg Confirmatory assays on the ADVIA Centaur systems. The performance of the HBsAg quality control material has not been established with any other HBsAg or HBsAg Confirmatory assays. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION / INDICATIONS |
|
N16895/S094 |
Soflens 38 (polymacon) soft contact lenses |
Bausch & Lomb |
Approval for an additional supplier for the raw material hydroxyethyl-methyl-methacrylate for polymacon and alphafilcon A soft contact lenses. |
|
P830055/S143 |
LCS® Total Knee System |
DePuy Orthopaedics, Incorporated |
Approval for an additional inspection step in the manufacturing process for the Distal and Posterior Augments and the Revision Step Wedges that provides additional assurance of purity, identity, strength or reliability of the device. |
|
P830060/S077 |
AID-B/BR and Ventak ICD |
Boston Scientific Corporation |
Approval to add the use of mineral oil to device labeling. |
|
P850048/S037 |
Access Hybritech PSA Reagents on the Access Immunoassay Systems |
Beckman Coulter, Inc. |
Approval for software changes to add process monitoring functionality to the current configuration of the Access 2 Immunoassay System through the implementation of a new software version 3.4.1. |
|
P860003/S075 |
THERAKOS® CELLEX® Photopheresis System |
THERAKOS, Inc. |
Approval for a change in the geometry of the stand-offs featured on the inner lower bowl cover of the CELLEX® Procedural Kit’s centrifuge bowl. |
|
P860057/S121 |
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis, |
Edwards Lifesciences, LLC |
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements. |
|
P870056/S067 |
Carpentier-Edwards Porcine Aortic Bioprosthesis, |
Edwards Lifesciences, LLC |
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements. |
|
P870077/S061 |
Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis, Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended Suture |
Edwards Lifesciences, LLC |
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements. |
|
P880006/S088 |
SENSOLOG/ DIALOG/ REGENCY PACEMAKERS |
St. Jude Medical |
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650. |
|
P880086/S242 |
AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT |
St. Jude Medical |
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650. |
|
P890003/S305 |
REVEAL DX. REVEAL XT, REVEAL LINQ INSERTABLE CARDIAC MONITOR |
Medtronic, Inc. |
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices. |
|
P890003/S306 |
My CareLink Patient Monitor |
Medtronic, Inc. |
Approval for firmware updates to the MyCareLink Patient Monitor 24950. |
|
P890003/S307 |
My CareLink Patient Monitor |
Medtronic, Inc. |
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices. |
|
P890055/S055 |
MedStream Programmable Infusion System |
Codman & Shurtleff, Inc. |
Approval for changes to quality control and manufacturing procedures to include additional steps verifying that a minimum of 66 hours have elapsed between the time that the MedStream pump battery is connected to the Printed Circuit Board (PCB) and before programming the PCB with the production diagnostic pump software. |
|
P890064/S030 |
Qiagen Digene Hybrid Capture 2 (HC2) HPV DNA Test; Qiagen Digene Hybrid Capture 2 (HC2) High Risk HPV DNA Test |
Qiagen Gaithersburg, Inc. |
Approval for the upgrade of the HC2 Software Suite to Version 4.2. |
|
P900009/S035 |
EXOGEN Ultrasound Bone Healing System |
Bioventus LLC |
Approval for a new Bioventus manufacturing facility in Cordova, Tennessee, manufacturing process changes, a rechargeable battery and charger, redesign of the main operating unit, changes to the instructions for use, and modified packaging. |
|
P900009/S036 |
Exogen Ultrasound Bone Healing System |
Bioventus LLC |
Approval for a manufacturing site in Cordova, Tennessee. |
|
P910023/S333 |
ELLIPSE/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER |
St. Jude Medical |
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650. |
|
P910073/S124 |
ENDOTAK RELIANCE 4-SITE Defibrillation Leads |
Boston Scientific Corporation |
Approval to add the use of mineral oil to device labeling. |
|
P910077/S141 |
VENTAK PRx, VENTAK MINI ICDs |
Boston Scientific Corporation |
Approval to add the use of mineral oil to device labeling. |
|
P940015/S028 |
Synvisc and Synvisc-One |
Nancy Immel |
Approval for changes to quality control test methods. |
|
P940031/S076 |
VIGOR, MERIDIAN, DISCOVERY Pacemakers |
Boston Scientific Corporation |
Approval to add the use of mineral oil to device labeling. |
|
P950037/S132 |
ENTOVIS PROMRI PACEMAKER SYSTEM |
Biotronik, Inc. |
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the supporting Programmer Software Version PSW 1307.U. When an Entovis Pacemaker is used in conjunction with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be identified as the Entovis ProMRI System. |
|
P960022/S009 |
Soflens Toric (alphafilcon A) soft Contact Lenses |
Bausch & Lomb |
Approval for an additional supplier for the raw material hydroxyethyl-methyl-methacrylate for polymacon and alphafilcon A soft contact lenses. |
|
P960040/S310 |
VENTAK AV, VENTAK PRIZM, VITALITY, CONFIENT, TELIGEN, INCEPTA, ENERGEN, PUNCTUA ICDs |
Boston Scientific Corporation |
Approval to add the use of mineral oil to device labeling. |
|
P960040/S312 |
Teligen, Punctua, Energen, and Incepta Implanable Cardioverter Defibrillators (ICD) and Punctua, Energen, and Incepta Cardiac Resynchronization Therapy Defibrillators |
Boston Scientific Corporation |
Approval for changes in trace cobalt control limit in raw MnO2 and trace calcium control limit in raw lithium foil for the pulse generator batteries. |
|
N970003/S159 |
PULSAR, PULSAR MAX, DISCOVERY, INSIGNIA, ALTRUA, |
Boston Scientific Corporation |
Approval to add the use of mineral oil to device labeling. |
|
N970003/S160 |
Advantio and Ingenio Pacemakers |
Boston Scientific Corporation |
Approval for changes in trace cobalt control limit in raw MnO2 and trace calcium control limit in raw lithium foil for the pulse generator batteries. |
|
P970013/S058 |
MICRONY PACEMAKERS |
St. Jude Medical |
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650. |
|
P970029/S026 |
TMR2000 Holmium Laser System |
Cardiogenesis |
Approval for including the Post Approval study labeling changes of the Pearl 8.0 device into the instructions for use of the Pearl 5.0 and the Sologrip III handpieces as well as adding some clarifying statements to ensure the safe handling of the handpieces. |
|
P970003/S166 |
VNS Therapy System |
Cyberonics, Inc. |
Approval for labeling that describes the conditions under which Magnetic Resonance Imaging (MRI) can be used when residual VNS Leads or Lead fragments (abandoned leads) remain in the body. |
|
P970038/S026 |
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems |
Beckman Coulter, Inc. |
Approval for software changes to add process monitoring functionality to the current configuration of the Access 2 Immunoassay System through the implementation of a new software version 3.4.1. |
|
P970051/S110 |
Nucleus 24 Cochlear Implant System |
Cochlear Americas |
Approval for a change to the assembly construction of external switches on the CP810 sound processor with the intention of improving ingress protection and therefore corrosion resistance. |
|
P980006/S015 |
PureVision 2 (balafilcon A) Visibility Tinted Contact Lens; |
Bausch & Lomb, Inc. |
Approval for an alternate packaging solution of borate buffered saline with 0.5% poloxamine for the balafilcon A contact lens product family. |
|
P980016/S472 |
EnTrust, Virtuoso, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso II, Insync |
Medtronic, Inc. |
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices. |
|
P980016/S474 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD |
Medtronic, Inc. |
Approval for a Replacement Telemetry M Component and Associated Manufacturing Changes. |
|
P980016/S477 |
EVERA, INTRINSIC, MARQUIS, MAXIMO, PROTECTA, SECURA, AND VIRTUOSO II IMPLANTABLE CARDIOVERTER |
Medtronic, Inc. |
Approval for firmware updates to the MyCareLink Patient Monitor 24950. |
|
P980016/S478 |
Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Intrinsic 30, Intrinsic, Marquis DR, Marquis VR, Maximo DR, Maximo II, Maximo VR, Protecta, Protecta XT, Secura, Virtuoso II DR/VR Family of ICDs |
Medtronic, Inc. |
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices. |
|
P980016/S479 |
Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD |
Medtronic, Inc. |
Approval for the changes of the deformation element (DE) in the high voltage capacitor electrical feedthrough for the devices. |
|
P980022/S153 |
Paradigm REAL-Time Revel System |
Medtronic MiniMed |
Approval for software changes to the Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-523K, MMT-723, and MMT-723K) application software. These changes include corrections for two motor error anomalies and enhancements for the Threshold Suspend feature, insulin value setting, and merged common code base. The Paradigm REAL-Time Revel Insulin Pump is a component of the Paradigm REAL-Time Revel System. |
|
P980035/S369 |
Advisa DR IPO, Advisa DR MRI IPG |
Medtronic, Inc. |
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices. |
|
P980035/S372 |
ADAPTA, VERSA, SENSIA, ADVISA, ENPULSE, AND KAPPA |
Medtronic, Inc. |
Approval for firmware updates to the MyCareLink Patient Monitor 24950. |
|
P980035/S373 |
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, EnPulse E1, EnPulse E2, Kappa D, Kappa DR, Kappa SR (Kappa 700 and Kappa 900), Kappa VDD (Kappa 700) family of IPGs |
Medtronic, Inc. |
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices. |
|
P980041/S027 |
Access AFP Reagents on the Access Immunoassay Systems |
Beckman Coulter, Inc. |
Approval for software changes to add process monitoring functionality to the current configuration of the Access 2 Immunoassay System through the implementation of a new software version 3.4.1. |
|
P990009/S037 |
Floseal Hemostatic Matrix |
Baxter Healthcare Corporation |
Approval for revised labeling to include a summary of the Nasso et al. clinical trial, update the device description, and extend the Thrombin reconstitution period. |
|
P990081/S028 |
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody |
Ventana Medical Systems, Inc. |
Approval for a new adhesive for the slide heaters on the BenchMark XT and ULTRA automated slide stainers. |
|
P000006/S034 |
Titan Inflatable Penile Prosthesis |
Coloplast Corporation |
Approval for an additional raw material supplier for the polyurethane spandex material used in the fabrication of Bioflex® dispersion (used to manufacture Titan reservoirs and cylinders). |
|
P000007/S046 |
Edwards Prima Plus Stentless Porcine Bioprosthesis |
Edwards Lifesciences, LLC |
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements. |
|
P000009/S057 |
Xelos DR-T Implantable Cardioverter |
Biotronik, Inc. |
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the supporting Programmer Software Version PSW 1307.U. When an Entovis Pacemaker is used in conjunction with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be identified as the Entovis ProMRI System. |
|
P000029/S076 |
Deflux |
Salix Pharmaceuticals, Inc. |
Approval for the introduction of in-house produced water for injection (WFI), as well as clearance for the use of pharmaceutical grade NaOH and HCl, rather than the grade currently used by the firm. |
|
P010012/S347 |
CONTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA |
Boston Scientific Corporation |
Approval to add the use of mineral oil to device labeling. |
|
P010012/S349 |
Cognis Cardiac Resynchronization Therapy Defibrillators (CRT-D) |
Boston Scientific Corporation |
Approval for changes in trace cobalt control limit in raw MnO2 and trace calcium control limit in raw lithium foil for the pulse generator batteries. |
|
P010013/S054 |
NovaSure Impedance Controlled Endometrial Ablation System |
Hologic, Inc. |
Approval of the post-approval study protocol. |
|
P010015/S236 |
CONSULTA CRT-P, SYNCRA CRT-P |
Medtronic, Inc. |
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices. |
|
P010015/S237 |
CONSULTA AND SYNCRA CARDIAC RESYNCHRONI- ZATION THERAPY PACEMAKERS |
Medtronic, Inc. |
Approval for firmware updates to the MyCareLink Patient Monitor 24950. |
|
P010015/S238 |
Consulta CRT-P, Syncra CRT-P |
Medtronic, Inc. |
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices. |
|
P010030/S049 5/19/14 |
LifeVest® Wearable Defibrillator |
ZOLL Lifecor Corporation |
Approval for 29 RoHS compliant alternate components, 7 RoHS compliant alternate bare-board subassemblies, and 6 RoHS compliant alternate cable subassemblies for use in the LifeVest Wearable Defibrillator. |
|
P010031/S433 |
Maximo II CRT-D, Concerto, Concerto II CRT-D, Consulta, InSync II Marquis, InSync III |
Medtronic, Inc. |
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices. |
|
P010031/S435 |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. |
Approval for a Replacement Telemetry M Component and Associated Manufacturing Changes. |
|
P010031/S438 |
BRAVA, CONCERTO, CONSULTA, INSYNC, MAXIMO II, |
Medtronic, Inc. |
Approval for firmware updates to the MyCareLink Patient Monitor 24950. |
|
P010031/S439 |
Brava CRT-D, Concerto ICD, Concerto II CRT-D, Consulta ICD, InSync II Protect ICD, InSync III Marquis ICD, InSync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D |
Medtronic, Inc. |
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices. |
|
P010031/S440 |
Brava CRT-D; Viva S CRT-D; Viva XT CRT-D |
Medtronic, Inc. |
Approval for the changes of the deformation element (DE) in the high voltage capacitor electrical feedthrough for the devices. |
|
P010041/S050 |
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis |
Edwards Lifesciences, LLC |
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements. |
|
P020055/S014 |
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody |
Ventana Medical Systems, Inc. |
Approval for a new adhesive for the slide heaters on the BenchMark XT and ULTRA automated slide stainers. |
|
P030004/S006 |
Onyx™ Liquid Embolic System (LES) |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Approval for the Apollo™ Onyx™ Delivery Micro Catheter that will be manufactured at Micro Therapeutics, Inc. d/b/a ev3 Neurovascular in Irvine, California. |
|
P030005/S106 |
CONTAK RENEWAL TR, INVIVE, INTUA CRT-Ps |
Boston Scientific Corporation |
Approval to add the use of mineral oil to device labeling. |
|
P030005/S107 |
Invive Cardiac Resynchronization Therapy Pacemakers (CRT-P) |
Boston Scientific Corporation |
Approval for changes in trace cobalt control limit in raw MnO2 and trace calcium control limit in raw lithium foil for the pulse generator batteries. |
|
P030017/S186 |
Precision Spectra SCS System |
Boston Scientific Corporation |
Approval for design changes to Precision Spectra OR Cable and Extension and an alternate qualified supplier (Onanon Inc. Milpitas, CA). |
|
P030035/S120 |
FRONTIER/ |
St. Jude Medical |
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650. |
|
P030054/S265 |
QUADRA ASSURA/UNIFY ASSURA CARDIAC |
St. Jude Medical |
Approval for the Model 3330 Version 18.1.1 Software for the Merlin Patient Care System Programmer Model 3650. |
|
P050010/S014 |
PRODISC L Total Disc Replacement |
DePuy Synthes Spine |
Approval to add additional endplates as a line extension. |
|
P050023/S074 |
Ilesto implantable cardioverter |
Biotronik, Inc. |
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the supporting Programmer Software Version PSW 1307.U. When an Entovis Pacemaker is used in conjunction with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be identified as the Entovis ProMRI System. |
|
P050050/S007 |
Scandinavian Total Ankle Replacement System (S.T.A.R. Ankle) |
Small Bone Innovations, Inc. |
Approval of the post-approval study protocol. |
|
P060019/S025 |
Therapy Cool Path Ablation Catheter & IBI-1500T9 RF Generator – Cool Point™ Tubing Set |
Irvine Biomedical, Inc. |
Approval for a design change in the tubing set material and package size for the Cool Point™ Tubing Set. |
|
P060037/S027 |
NexGen LPS Flex Mobile Bearing Knee |
Zimmer, Incorporated |
Approval for new testing equipment. |
|
P060037/S028 |
NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee |
Zimmer, Incorporated |
Approval for addition of a new manufacturing area with new equipment. |
|
P070008/S050 |
Evia cardiac resynchronization therapy |
Biotronik, Inc. |
Approval for MRI-conditional labeling for the Entovis SR / SR-T / DR / DR-T pacemakers, and the supporting Programmer Software Version PSW 1307.U. When an Entovis Pacemaker is used in conjunction with Setrox S 53/60 or Safio 53/60 pacemaker leads it shall be identified as the Entovis ProMRI System. |
|
P070015/S119 |
XIENCE V® Everolimus Eluting Coronary Stent System (RX and OTW); |
Abbott Vascular |
Approval for a change in the resin composition of polypropylene supply items used in XIENCE primer and drug formulation manufacturing. |
|
P070026/S021 |
Ceramax Ceramic Hip System |
Depuy, Inc. |
Approval of the post-approval study protocol. |
|
P080006/S063 |
Attain Ability Lead |
Medtronic CRDM |
Approval for changes to the monolithic controlled release device (MCRD) elution method and specifications, transfer of the MCRD manufacturing location, use of a surrogate tip component for MCRD testing, and updates to the MCRD shelf life protocol for Attain Ability lead models 4196, 4296 and 4396. |
|
P090013/S136 |
Revo MRI |
Medtronic, Inc. |
Approval for firmware updates (version CM2490G_15v6) to the CareLink Monitor Model 2490G CareLink Home Monitors, Model 2020A Cardiosight Reader, and Model 2020B CareLink Express for a variety of implanted devices. |
|
P090013/S138 |
REVO MRI IPG |
Medtronic, Inc. |
Approval for firmware updates to the MyCareLink Patient Monitor 24950. |
|
P090013/S139 |
Revo MRI IPG |
Medtronic, Inc. |
Approval for minor hardware and firmware changes to the MyCareLink Patient Monitor Model 24955 RF Head for the devices. |
|
P090026/S010 |
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems |
Beckman Coulter, Inc. |
Approval for software changes to add process monitoring functionality to the current configuration of the Access 2 Immunoassay System through the implementation of a new software version 3.4.1. |
|
P100003/S003 |
Secure-C Artificial Cervical Disc |
Globus Medical, Inc. |
Approval of the post-approval study protocol. |
|
P100009/S005 |
MitraClip & Clip Delivery System |
Abbott Vascular |
Approval for a labeling change that included additions to the list of anticipated events and converting certain procedural caution statements to warning statements. |
|
P100014/S012 |
Solesta |
Salix Pharmaceuticals, Inc. |
Introduction of in-house produced water for injection (WFI). |
|
P100021/S035 |
Endurant and Endurant II Stent Graft System |
Medtronic Vascular |
Approval for clarifications made to the rear handle assembly manufacturing process procedures. |
|
P100021/S036 |
Endurant and Endurant II Stent Graft System |
Medtronic Vascular |
Approval for minor clarifications to the hydrophilic coating procedures. |
|
P100023/S080 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System |
Boston Scientific |
Approval to reduce the Kinetic Drug Release (KDR) sample quantity for batch release and stability testing. |
|
P100026/S011 |
RNS® System |
NeuroPace, Inc. |
Approval for the addition of Ethernet connectivity to access the Patient Data Management System database. |
|
P100027/S017 |
INFORM HER2 Dual ISH DNA Probe |
Ventana Medical Systems, Inc. |
Approval for a new adhesive for the slide heaters on the BenchMark XT and ULTRA automated slide stainers. |
|
P100029/S015 |
Trifecta™ Valve |
St. Jude Medical, Inc. |
Approval for an alternate bacterial endotoxin sampling/testing plan for the Trifecta™ valve. |
|
P100041/S050 |
Edwards SAPIEN Transcatheter Heart Valve and Accessories |
Edwards Lifesciences, LLC |
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements. |
|
P110002/S001 |
Mobi-C Cervical Disc |
LDR Spine USA, Inc. |
Approval of the post-approval study protocol. |
|
P110004/S002 |
NIRxcell CoCr Coronary Stent on RX System |
Medinol Ltd. |
Approval for a modification to the D-catheter tip spring. |
|
P110009/S001 |
Mobi-C Cervical Disc |
LDR Spine USA, Inc. |
Approval of the post-approval study protocol. |
|
P110009/S002 |
Mobi-C Cervical Disc |
LDR Spine USA, Inc. |
Approval of the post-approval study protocol. |
|
P110014/S002 |
MarginProbe System |
Dune Medical, Ltd. |
Approval for a manufacturing site located at Medimor Ltd., in Tiberias, Israel (contract manufacturer). |
|
P110019/S060 |
XIENCE PRIME® Everolimus Eluting Coronary Stent System (RX); |
Abbott Vascular |
Approval for a change in the resin composition of polypropylene supply items used in XIENCE primer and drug formulation manufacturing. |
|
P110021/S037 |
Edwards SAPIEN Transcatheter Heart Valve and Accessories |
Edwards Lifesciences, LLC |
Approval for upgrading the printed circuit board (PCB) of the Sensitech agAlert® temperature indicator with minor hardware enhancements. |
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/S162 |
ADVANTIO™ Implantable Pulse Generator (PG); |
Boston Scientific Corporation |
Adding an alternate Oscillator Crystal component to hybrid bill of materials for the devices. |
|
N970003/S163 |
ADVANTIO; INGENIO; VITALIO; FORMIO Pacemaker |
Boston Scientific Corporation |
Use an alternate inspection method and equipment with a corresponding specification change. |
|
N970003/S164 |
FORMIO, VITALIO, ADVANTIO, INGENIO Pacemakers |
Boston Scientific Corporation |
Addition of a second Pulse Generator (PG) device header overmolding Main Line 2 at the Clonmel manufacturing facility. |
|
P790002/S032 |
Biomet EBI Bone Healing System |
EBI, LLC, d/b/a Biomet Spine & Bone Healing Technologies |
Addition of new labeling equipment. |
|
P790007/S041 |
Hancock® Modified Orifice Valved Conduit |
Medtronic Heart Valves |
Addition of new porcine tissue suppliers. |
|
P810006/S052 |
Collastat Absorbable Collagen Hemostatic Sponge, Collastat |
Integra Life Sciences Corporation |
Qualification of a new AirLock Room. |
|
P830060/S079 |
Suture Sleeve, Lead Cap, Medical Adhesive, Stylet |
Boston Scientific Corporation |
Add an identical Sterilization Chamber to the St. Paul manufacturing facility. |
|
P840001/S268 |
SCS Neurostimulators Implantable Restore Family |
Medtronic, Inc. |
Update the software used at the Medtronic Tempe Campus. |
|
P840062/S039 |
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound |
Integra Life Sciences Corporation |
Qualification of a new AirLock Room. |
|
P850010/S052 |
Helistat, Helitene Absorbable Collagen Hemostatic Agents |
Integra Life Sciences Corporation |
Qualification of a new AirLock Room. |
|
P850022/S022 |
Biomet OrthoPak Non-invasive Bone Growth Stimulator System & Biomet SpinalPak Non-invasive Spine Fusion Stimulator System |
EBI, LLC, d/b/a Biomet Spine & Bone Healing Technologies |
Addition of new labeling equipment. |
|
P850068/S010 |
Silsoft® (elastofilcon A) Contact Lenses |
Bausch & Lomb, Inc. |
Acceptance of an alternate autoclave. |
|
P850068/S011 |
Silsoft (Elastofilcon A) Contact Lens |
Bausch & Lomb, Inc. |
Replacement of the laser etching system. |
|
P860057/S123 |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprostheses |
Edwards Lifesciences, LLC |
Addition of an alternate tissue supplier. |
|
P860057/S24 |
Carpentier-Edwards PERIMOUNT Pericardia Aortic and Mitral Bioprosthesis |
Edwards Lifesciences, LLC |
Upgrade of the valve flow and leaflet coaptation tester. |
|
P870078/S025 |
Hancock® Low Porosity Valved Conduit |
Medtronic Heart Valves |
Addition of new porcine tissue suppliers. |
|
P890003/S308 |
MyCareLink Patient Monitor |
Medtronic, Inc. |
Test changes to the telemetry module. |
|
P900033/S034 |
Integra Dermal Regeneration Template |
Integra Life Sciences Corporation |
Qualification of a new AirLock Room. |
|
P900056/S137 |
Rotablator Rotational Atherectomy System |
Boston Scientific Corporation |
Change to add a new ethylene oxide sterilization chamber. |
|
P900056/S138 |
Rotablator Rotational Atherectomy System |
Boston Scientific Corporation |
Change to the Incoming Inspection site for the Rotablator Console components from Fremont, California to San Jose, California. |
|
P910007/S043 |
ARCHITECT Total Free PSA |
Abbott Laboratories Abbott Park, IL 60064 |
Revision of the quality control test method to allow the AxSYM Total and Free PSA test methods to be replaced by the ARCHITECT Total and Free PSA test methods for the manufacture of PSA Panel H. |
|
P910007S044 |
ARCHITECT Total PSA |
Abbott Laboratories, Abbott Park, IL 60064 |
Changes to the quality control testing used to assess the suitability of in-process ARCHITECT Total PSA bulk secondary calibrator materials and ARCHITECT Free PSA bulk product calibrator/ control materials. |
|
P910023/S334 |
FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES |
St. Jude Medical |
Change to the integrated circuit component rework procedure. |
|
P910023/S335 |
Current DR, Current DR RF, Current Accel DR, Current+ DR, Current VR, Current VR RF, Current Accel VR, Current+ VR, Ellipse DR, Ellipse VR, Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR |
St. Jude Medical |
Use of an alternate electrolyte supplier for the high voltage capacitors used in the devices. |
|
P910062/S004 |
STAR S41R Excimer Laser System and WaveScan WaveFront System |
AMO Manufacturing USA, LLC |
Change of the Frame Grabber Printed Circuit Board (PCB) of the STAR system. |
|
P910062/S006 |
STAR S4 IR Excimer Laser System and WaveScan WaveFront System |
AMO Manufacturing USA, LLC |
Addition of a re-polishing process for the Hex Prism assembly, of the STAR system. |
|
P910073/S125 |
ENDOTAK TRANSVENOUS DEFIBRILLATION SYSTEM |
Boston Scientific Corporation |
Add an identical Sterilization Chamber to the St. Paul manufacturing facility. |
|
P910077/S142 |
VENTAK PRX AICD SYSTEM. PRESCRIPTOR PROGRAMMER AND PROGRAM AND PROGRAM DISK |
Boston Scientific Corporation |
Add an identical Sterilization Chamber to the St. Paul manufacturing facility. |
|
P920047/S069 |
Blazer II Cardiac Ablation Catheter and Cable |
Boston Scientific Corporation |
Change to add a new ethylene oxide sterilization chamber. |
|
P920047/S070 |
Blazer II, Blazer II HTD, Blazer Prime HTD Temperature Ablation |
Boston Scientific Corporation |
Acceptance to replace an existing manual process with an automated process. |
|
P930016/S040 |
STAR S41R Excimer Laser System and WaveScan WaveFront System |
AMO Manufacturing USA, LLC |
Change of the Frame Grabber Printed Circuit Board (PCB) of the STAR system. |
|
P930016/S042 |
STAR S4 IR Excimer Laser System and WaveScan WaveFront System |
AMO Manufacturing USA, LLC |
Addition of a re-polishing process for the Hex Prism assembly, of the STAR system. |
|
P930029/S043 |
Atakr® Radio Frequency (RF) Catheter Ablation System |
Medtronic, Inc. |
Change to the process controls on the part of a supplier to verify insulation between thermocouple double wires. |
|
P930031/S052 |
WALLSTENT TIPS Endoprosthesis |
Boston Scientific Corp. |
Relocation of the manufacturing for the E-tube component from one Boston Scientific Corporation facility to another. |
|
P930035/S026 |
VENTAK P2 AICD SYSTEM |
Boston Scientific Corporation |
Add an identical Sterilization Chamber to the St. Paul manufacturing facility. |
|
P930039/S108 |
CapSureFix Novus Lead |
Medtronic CRDM |
Tip grinding process improvement for helix components. |
|
P940008/S031 |
RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS |
Boston Scientific Corporation |
Add an identical Sterilization Chamber to the St. Paul manufacturing facility. |
|
P940015/S032 |
Synvisc and Synvisc-One |
Genzyme Corporation |
Addition of an automated system. |
|
P940019/S044 |
WALLSTENT Iliac Endoprosthesis |
Boston Scientific Corp. |
Relocation of the manufacturing for the E-tube component from one Boston Scientific Corporation facility to another. |
|
P940031/S077 |
VIGOR DR PACEMAKER SYSTEM/VIGOR SR PACEMAKER SYSTEM |
Boston Scientific Corporation |
Add an identical Sterilization Chamber to the St. Paul manufacturing facility. |
|
P960004/S065 |
THINLINE AND FINELINE TRANSVENOUS ENDOCARDIAL PACING LEADS |
Boston Scientific Corporation |
Add an identical Sterilization Chamber to the St. Paul manufacturing facility. |
|
P960006/S042 |
FLEXTEND PACING LEADS AND FIXATION TOOL |
Boston Scientific Corporation |
Add an identical Sterilization Chamber to the St. Paul manufacturing facility. |
|
P960009/S194 |
DBS Neurostimulators Implantable Activa Family |
Medtronic, Inc. |
Update the software used at the Medtronic Tempe Campus. |
|
P960011/S024 |
BVI 1% Ophthalmic Viscosurgical Devices (OVD) |
Ferring Pharmaceuticals, Inc. |
Use of a new intermediate vessel for BVI 1% and EUFLEXXA OVD. |
|
P960040/S313 |
PUNCTUA ICDs, TELIGEN ICDs, ENERGEN ICDs, INCEPTA ICDs |
Boston Scientific Corporation |
Manufacturing changes to the capacitor parylene measurement. |
|
P960040/S314 |
PUNCTUA ICDs; TELIGEN ICDs; ENERGEN ICDs; INCEPTA ICDs; ORIGEN ICDs; INOGEN ICDs; DYNAGEN ICDs |
Boston Scientific Corporation |
Use an alternate inspection method and equipment with a corresponding specification change. |
|
P960040/S315 |
DYNAGEN, INOGEN, ORIGEN ICDs |
Boston Scientific Corporation |
Addition of a second Pulse Generator (PG) device header overmolding Main Line 2 at the Clonmel manufacturing facility. |
|
P970020/S080 |
MULTI-LINK ULTRA®/ MULTI-LINK ZETA® Coronary Stent |
Abbott Vascular |
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories. |
|
P970031/S045 |
Freestyle® Aortic Root Bioprosthesis |
Medtronic Heart Valves |
Addition of new porcine tissue suppliers. |
|
P970051/S119 |
Nucleus 24 Cochlear Implant System |
Cochlear Americas |
Acceptance of a new surgical instrument supplier. |
|
P980003/S049 |
Chilli II Cooled Ablation Catheter and Cable |
Boston Scientific Corporation |
Change to add a new ethylene oxide sterilization chamber. |
|
P980007/S034 |
ARCHITECT Free PSA |
Abbott Laboratories Abbott Park, IL 60064 |
Revision of the quality control test method to allow the AxSYM Total and Free PSA test methods to be replaced by the ARCHITECT Total and Free PSA test methods for the manufacture of PSA Panel H. |
|
P980007/S035 |
ARCHITECT Free PSA |
Abbott Laboratories, Abbott Park, IL 60064 |
Changes to quality control testing used on in- process materials-ARCHITECT Free PSA bulk secondary calibrators and ARCHITECT Free PSA bulk product calibrators/controls. |
|
P980016/S480 |
Evera ICDs |
Medtronic, Inc. |
Test changes to the telemetry module. |
|
P980016/S482 |
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD |
Medtronic, Inc. |
Update to the Next Generation Hybrid Tester process. |
|
P980016/S483 |
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD |
Medtronic, Inc. |
Change in the AVX capacitor lapping process used in the devices. |
|
P980022/S155 |
Paradigm REAL-Time Continuous Glucose Monitoring System, Paradigm REAL-Time Revel Continuous Glucose Monitoring System, |
Medtronic MiniMed |
New tool to be used in the process of curing the vibrator motor to the vibrator motor housing in the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K, MMT-722, MMT-722K), a component of the Paradigm REAL-Time Continuous Glucose Monitoring System, the Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K, MMT-723, MMT-723K), a component of the Paradigm REAL-Time Revel Continuous Glucose Monitoring System, and the Guardian REAL-Time Continuous Glucose Monitoring System. |
|
P980033/S041 |
WALLSTENT Venous Endoprosthesis |
Boston Scientific Corp. |
Relocation of the manufacturing for the E-tube component from one Boston Scientific Corporation facility to another. |
|
P980035/S375 |
Advisa DR IPG, Advisa DR MRI IPG |
Medtronic CRDM |
Antenna wire bond coat manufacturing standardization for the devices. |
|
P980035/S376 |
Advisa DR and Advisa DR MRI IPGs |
Medtronic, Inc. |
Changes to the leak test system. |
|
P980043/S045 |
Hancock® II Porcine Bioprosthesis |
Medtronic Heart Valves |
Addition of new porcine tissue suppliers. |
|
P980044/S018 |
SUPARTZ |
Seikagaku Corporation |
Addition of two new raw material storage rooms. |
|
P990010/S004 |
STAR S41R Excimer Laser System and WaveScan WaveFront System |
AMO Manufacturing USA, LLC |
Change of the Frame Grabber Printed Circuit Board (PCB) of the STAR system. |
|
P990010/S006 |
STAR S4 IR Excimer Laser System and WaveScan WaveFront System |
AMO Manufacturing USA, LLC |
Addition of a re-polishing process for the Hex Prism assembly, of the STAR system. |
|
P990064/S054 |
Mosaic® Porcine Bioprosthesis |
Medtronic Heart Valves |
Addition of new porcine tissue suppliers. |
|
P000020/S018 |
Bard Ablation System |
Boston Scientific Corporation |
Acceptance to implement an additional supplier to perform machining of the ablation catheter handle components. |
|
P000023/S010 |
Fossa-Eminence and Condylar Prothesis System |
Nexus CMF, LLC |
Add water quality standards. |
|
P000029/S077 |
Deflux Injectable Gel |
Salix Pharmaceuticals, Inc. |
Expansion of the firm’s clean room production area. |
|
P000035/S010 |
TMJ Fossa-Eminence Prosthesis System |
Nexus CMF, LLC |
Add water quality standards. |
|
P010012/S350 |
PUNCTUA CRT-D, COGNIS CRT-Ds, |
Boston Scientific Corporation |
Manufacturing changes to the capacitor parylene measurement. |
|
P010012/S351 |
INVIVE™ Cardiac Resynchronization Therapy Pacemaker (CRT-P); INTUA™ CRT-P |
Boston Scientific Corporation |
Adding an alternate Oscillator Crystal component to hybrid bill of materials for the devices. |
|
P010012/S352 |
CONTAK CD CRT-D &EASYTRAK CORONARY VENOUS STEROID ELUTING SINGLE ELCTRODE PACE/SENSE LEAD |
Boston Scientific Corporation |
Add an identical Sterilization Chamber to the St. Paul manufacturing facility. |
|
P010012/S353 |
PUNCTUA CRT-Ds; COGNIS CRT-Ds; ENERGEN CRT-Ds; INCEPTA CRT-Ds; ORIGEN CRT-Ds; INOGEN CRT-Ds; DYNAGEN |
Boston Scientific Corporation |
Use an alternate inspection method and equipment with a corresponding specification change. |
|
P010012/S354 |
DYNAGEN, INOGEN, ORIGEN CRT-Ds |
Boston Scientific Corporation |
Addition of a second Pulse Generator (PG) device header overmolding Main Line 2 at the Clonmel manufacturing facility. |
|
P010013/S055 |
NovaSure Impedance Controlled Endometrial Ablation System |
Hologic, Inc. |
Change in the leak test performed on the RF controller manifold subassembly. |
|
P010015/S239 |
Consulta and Syncra Cardiac Resynchronization Therapy – Pacemakers |
Medtronic, Inc. |
Changes to the leak test system. |
|
P010015/S240 |
Consulta CRT-P, Syncra CRT-P |
Medtronic, Inc. |
Add an additional ultrasonic weld (USW) to connect the connector sub-assembly to the radiopaque component. |
|
P010029/S020 |
EUFLEXXA Ophthalmic Viscosurgical Devices (OVD) |
Ferring Pharmaceuticals, Inc. |
Use of a new intermediate vessel for BVI 1% and EUFLEXXA OVD. |
|
P010031/S441 |
Brava, Viva |
Medtronic, Inc. |
Test changes to the telemetry module. |
|
P010031/S444 |
Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D |
Medtronic, Inc. |
Update to the Next Generation Hybrid Tester process. |
|
P010031/S445 |
Brava CRT-D, Concerto II CRT-D, |
Medtronic, Inc. |
Change in the AVX capacitor lapping process used in the devices. |
|
P010033/S024 |
QuantiFERON®-TB Gold In-Tube |
Cellestis Incorporated |
Change to the location of manufacturing activities within the same previously approved establishment for the Contract Manufacturing Organization. |
|
P020004/S093 |
GORE® EXCLUDER® AAA Endoprosthesis |
W.L. Gore & Associates, Inc. |
Addition of an automated dual head wrapper. |
|
P020004/S094 |
EXCLUDER AAA Endoprosthesis |
W.L. Gore & Associates, Inc. |
New supplier for biological indicators. |
|
P020009/S121 |
Express2 Monorail and OTW Coronary Stent System |
Boston Scientific Corporation |
Change to add a new ethylene oxide sterilization chamber. |
|
P020025/S057 |
Blazer II XP Cardiac Ablation Catheter and Cable |
Boston Scientific Corporation |
Change to add a new ethylene oxide sterilization chamber. |
|
P020025/S058 |
Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP Temperature Ablation |
Boston Scientific Corporation |
Acceptance to replace an existing manual process with an automated process. |
|
P020036/S028 |
SMART Control Nitinol Stent Systems |
Cordis Corporation |
Change in manufacturing facility for the supplier of the slider assembly and handle and the introduction of a new molding machine. |
|
P020045/S053 |
Freezor, Freezor MAX and Freeze Xtra Cryoablation Devices |
Medtronic CryoCath LP |
Change to the type of test catheter used during Cryoconsole manufacturing and field installation testing. |
|
P020047/S008 |
MULTI-LINK VISION®/ MULTI-LINK MINI VISION®/ |
Abbott Vascular |
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories. |
|
P030002/S031 |
Crystalens and Trulign Toric Intraocular Lens |
Bausch & Lomb, Inc. |
Acceptance of a microbiological testing facility and the repurposing of a manufacturing room. |
|
P030005/S109 |
INVIVE CRT Ps; INTUA CRT Ps |
Boston Scientific Corporation |
Use an alternate inspection method and equipment with a corresponding specification change. |
|
P030005/S110 |
INVIVE, INTUA CRT-Ps |
Boston Scientific Corporation |
Addition of a second Pulse Generator (PG) device header overmolding Main Line 2 at the Clonmel manufacturing facility. |
|
P030009/S077 |
Integrity Coronary Stent Systems |
Medtronic Inc. |
Upgrade to the Wire Forming machine that is currently used on Integrity stents. |
|
P030009/S078 |
Integrity Coronary Stent System |
Medtronic Vascular |
Change to the stent sub-assembly manufacturing equipment. |
|
P030017/S194 |
Precision Spectra Spinal Cord Stimulator System |
Boston Scientific Corporation |
Add an alternate wire bonder. |
|
P030017/S195 |
Precision Spectra Spinal Cord Stimulator System |
Boston Scientific Corporation |
Add an alternate qualified supplier for thick film resistors. |
|
P030022/S030 |
REFLECTION Ceramic Acetabular Hip System (RCHS) |
Smith & Nephew, Inc. |
Introduce a new tray sealer to the packaging process. |
|
P030054/S266 |
QUADRA ASSURA, UNIFY, UNIFY ASSURA |
St. Jude Medical |
Change to the integrated circuit component rework procedure. |
|
P030054/S267 |
Promote, Promote |
St. Jude Medical |
Use of an alternate electrolyte supplier for the high voltage capacitors used in the devices. |
|
P040016/S127 |
VeriFLEX (Liberté) Coronary Stent System |
Boston Scientific Corporation |
Change to add a new ethylene oxide sterilization chamber. |
|
P040027/S033 |
VIATORR TIPS Endoprosthesis |
W.L. Gore & Associates, Inc. |
New supplier for biological indicators. |
|
P040037/S063 |
VIABAHN Endoprosthesis |
W.L. Gore & Associates, Inc. |
New supplier for biological indicators. |
|
P040043/S061 |
TAG Thoracic Endoprosthesis |
W.L. Gore & Associates, Inc. |
New supplier for biological indicators. |
|
P040044/S053 |
Mynx® Vascular Closure Device Product Family |
Access Closure, Inc. |
Implementation of a different sterilization configuration for the Mynx® Product Family of devices. |
|
P040044/S055 |
Mynx Vascular Closure Device Product Family |
Access Closure, Inc. |
Manufacturing process changes for cutting and drying the Hydrogel cakes of the Mynx Vascular Closure Device Product Family. |
|
P050006/S038 |
HELEX Septal Occluder |
W.L. Gore & Associates, Inc. |
New supplier for biological indicators. |
|
P050033/S017 |
Hydrelle |
Anika Therapeutics, Incorporated |
Transfer of residual solvent release testing from S&N Laboratories to in-house testing at Anika Therapeutics. |
|
P050037/S048 |
Radiesse Dermal Filler |
Merz North America, Inc. |
Automation of the filling process for the Radiesse product. |
|
P050052/S053 |
Radiesse Dermal Filler |
Merz North America, Inc. |
Automation of the filling process for the Radiesse product. |
|
P060006/S059 |
Express SD Renal Monorail Premounted Stent System |
Boston Scientific Corporation |
Change to add a new ethylene oxide sterilization chamber. |
|
P060040/S035 |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) |
Thoratec Corporation |
Addition of a supplier for the sintering process for the HeartMate II LVAS components. |
|
P070015/S123 |
XIENCE V® Everolimus Eluting Coronary Stent Systems |
Abbott Vascular |
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories. |
|
P080012/S020 |
Prometra Programmable Infusion Pump System |
Flowonix Medical, Inc. |
Alternate Electronic Modules Random Access Memory (RAM). |
|
P080020/S007 |
Gel-One |
Seikagaku Corporation |
Addition of two new raw material storage rooms. |
|
P090013/S140 |
Revo MRI IPG |
Medtronic CRDM |
Antenna wire bond coat manufacturing standardization for the devices. |
|
P090013/S141 |
REVO MRI Implantable Pulse Generators (IPG) |
Medtronic, Inc. |
Changes to the leak test system. |
|
P090013/S142 |
CapSureFix MRI Lead |
Medtronic CRDM |
Tip grinding process improvement for helix components. |
|
P100021/S034 |
Endurant Stent Graft System |
Medtronic Vascular |
Change to the sterilization load configuration. |
|
P100021/S037 |
Endurant Stent Graft System |
Medtronic Vascular |
Relocation of a second tier supplier of a critical component. |
|
P100023/S094 |
ION (Taxus Element) Coronary Stent System |
Boston Scientific Corporation |
Change to add a new ethylene oxide sterilization chamber. |
|
P100023/S095 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire |
Boston Scientific Corporation |
Change to the stent inspection requirements. |
|
P100023/S097 |
ION™ Paclitaxel- Eluting Coronary Stent System (Monorail and Over-The-Wire Systems) |
Boston Scientific Corporation |
Change to use a color camera for the distal tip inspection process. |
|
P100026/S016 |
Neuropace RNS System |
NeuroPace, Inc. |
Add alternate equipment. |
|
P100040/S019 |
Valiant Stent Graft with the Captivia Delivery System |
Medtronic Vascular |
Change to the sterilization load configuration. |
|
P100041/S052 |
Edwards SAPIEN® Transcatheter Heart Valve |
Edwards Lifesciences, LLC |
Addition of an alternate tissue supplier. |
|
P100041/S053 |
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories |
Edwards Lifesciences, LLC |
Changes to the manufacturing fixtures used in the manufacturing of the RetroFlex 3 Delivery System. |
|
P100044/S016 |
Propel and Propel Mini Sinus Implants |
Intersect ENT |
Addition of a new pouch sealing equipment, Sencorp White Heat Sealer with Vaccuum and Gas Purge Model 12-PV/2, to the existing manufacturing line for the packaging of the Propel and Propel Mini Sinus Implants. |
|
P110002/S006 |
LDR Spine |
LDR Spine USA, Inc. |
Modifications to several final inspections. |
|
P110004/S003 |
NIRxcell CoCr Coronary Stent on RX System |
Medinol Ltd. |
Addition of a new clean room to the Medinol Jerusalem manufacturing plant. |
|
P110009/S006 |
LDR Spine |
LDR Spine USA, Inc. |
Modifications to several final inspections. |
|
P110010/S079 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System |
Boston Scientific Corporation |
Change to add a new ethylene oxide sterilization chamber. |
|
P110010/S080 |
PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire |
Boston Scientific Corporation |
Change to the stent inspection requirements. |
|
P110010/S082 |
PROMUS Element™ Plus/Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System |
Boston Scientific Corporation |
Upgrade to the current Integrated Crimp and Cone Puff (ICCP) machines such that functionalities associated with the Non-Contact Measurement System (NCMS) will be combined with the ICCP on one machine. |
|
P110010/S084 |
PROMUS® Element™ Plus Everolimus-Eluting Coronary Stent System |
Boston Scientific Corporation |
Change to use a color camera for the distal tip inspection process. |
|
P110013/S039 |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System |
Medtronic Inc. |
Upgrade to the Wire Forming machine that is currently used on Integrity stents. |
|
P110013/S040 |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System |
Medtronic Vascular |
Change to the stent sub-assembly manufacturing equipment. |
|
P110019/S067 |
XIENCE PRIME®/XIENCE Xpedition® Everolimus Eluting |
Abbott Vascular |
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories. |
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P110021/S039 |
Edwards SAPIEN® Transcatheter Heart Valve |
Edwards Lifesciences, LLC |
Addition of an alternate tissue supplier. |
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P110021/S040 |
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories |
Edwards Lifesciences, LLC |
Changes to the manufacturing fixtures used in the manufacturing of the RetroFlex 3 Delivery System. |
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P110035/S025 |
Epic Vascular Self-Expanding Stent System |
Boston Scientific Corp. |
Changes to the ethylene oxide sterilization process. |
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P110035/S027 |
Epic Vascular Self-Expanding Stent System |
Boston Scientific Corp. |
Relocation of the manufacturing for the E-tube component from one Boston Scientific Corporation facility to another. |
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P110042/S033 |
Subcutaneous Implantable Defibrillator |
Cameron Health, Inc. |
Transfer the final package for the EIT from Cameron to Cameron’s contract manufacturer Boston Scientific Corporation (BSC). |
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P110042/S034 |
Subcutaneous Implantable Defibrillator |
Cameron Health, Inc. |
Add a dropout voltage variation test in the manufacturing process for the S-ICD pulse generator. |
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P110042/S035 |
SQ-RX Pulse Generator |
Boston Scientific CRM |
Changes related to manufacturing process of the battery including qualifying a new weld machine, modifying the insulating tape used in shipping, and new fixtures. |
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P110043/S006 |
Omnilink Elite® Vascular Stent Systems |
Abbott Vascular |
Addition of receiving inspection and testing activities of raw materials and supply items at the Clonmel, Ireland facility and contract laboratories. |
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P120002/S003 |
SMART Control Vascular Stent Systems |
Cordis Corporation |
Change in manufacturing facility for the supplier of the slider assembly and handle and the introduction of a new molding machine. |
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P120005/S017 |
Dexcom G4 PLATINUM Continuous Glucose Monitoring System |
Dexcom, Inc. |
Change for the method of measurement of critical dimensions during receiving inspection of the Dexcom G4 PLATINUM transmitter tray, and the use of a food grade silicone spray during manufacturing of the transmitter tray. |
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P120010/S020 |
MiniMed 530G System |
Medtronic MiniMed |
Change to the laser cutting program parameters of the Resonetics Galvo Laser System. |
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P120010/S022 |
MiniMed 530G System |
Medtronic MiniMed |
Addition of an automated cleaning system for components used in the Enlite Sensor, which is a component of the MiniMed 530G System. |
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P130006/S003 |
VIABAHN Endoprosthesis |
W.L. Gore & Associates, Inc. |
New supplier for biological indicators. |
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