| EPICARDIAL PATCH LEAD (P900061/S145) | Medtronic Cardiac Rhythm Disease Management | 2017-02-14 |
| MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 (P950024/S072) | Medtronic, Inc. | 2017-02-14 |
| DYNAGEN, INOGEN, ORIGEN, AUTOGEN CARDIAC RESYNCHRONIZATION THERAPYN DEFIBRILLATOR (CRT_D) (P010012/S444) | Boston Scientific Corp | 2017-02-14 |
| ACRYSOF IQ TORIC IOL WITH THE ULTRASERT PRE LOADED DELIVERY SYSTEM MODELS (P930014/S097) | Alcon Laboratories, Inc. | 2017-02-14 |
| CARDIOMEMS HF SYSTEM (P100045/S018) | ABBOTT MEDICAL | 2017-02-14 |
| CARDIOMEMS HF SYSTEM (P100045/S014) | ABBOTT MEDICAL | 2017-02-14 |
| ACCESS PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER (P850048/S044) | Beckman Coulter, Inc. | 2017-02-14 |
| DYNAGEN, INOGEN, ORIGEN, AUTOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P960040/S388) | Boston Scientific | 2017-02-14 |
| IS-1 CONNECTOR PORT PIN PLUG KIT, SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD (P920015/S195) | Medtronic, Inc. | 2017-02-14 |
| ATTAIN STARFIX MODEL 4195 LEAD (P060039/S077) | Medtronic, Inc. | 2017-02-14 |
| CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD (P830061/S142) | Medtronic Cardiac Rhythm Disease Management | 2017-02-14 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S106) | Medtronic, Inc. | 2017-02-14 |
| Visia AF software SW035 Version 8.1 (P980016/S615) | Medtronic Cardiac Rhythm Disease Management | 2017-02-14 |
| ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER (P980041/S035) | Beckman Coulter, Inc. | 2017-02-14 |
| TRANSVENE CS/SVC LEAD (P980050/S109) | Medtronic, Inc. | 2017-02-14 |
| APTIMA HCV QUANT DX ASSAY (P160023) | Hologic, Inc. | 2017-02-13 |
| INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S024) | Boston Scientific Corporation | 2017-02-13 |
| METHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES (P850079/S072) | CooperVision, Inc. | 2017-02-13 |
| FLOSEAL HEMOSTATIC MATRIX (P990009/S044) | Baxter Healthcare Corp | 2017-02-10 |
| AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S121) | Boston Scientific Corp | 2017-02-10 |
| BIOGLUE SURGICAL ADHESIVE (P010003/S023) | Cryolife, Inc. | 2017-02-10 |
| PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) (P070008/S077) | Biotronik, Inc. | 2017-02-10 |
| Guardian Link (3) Transmitter (P160017/S008) | Medtronic Minimed, Inc. | 2017-02-10 |
| NIRXCELL PMS US STUDY NIRTRAKS (P110004/S021) | Medinol, Ltd. | 2017-02-10 |
| PULSE GENERATOR, PERMANENT, IMPLANTABLE (P950037/S169) | Biotronik, Inc. | 2017-02-10 |
| VALIANT THORACIC STENT GRAFT SYSTEM (P100040/S029) | Medtronic Vascular | 2017-02-09 |
| WOLVERINE CORONARY CUTTING BALLOON (MONORAIL AND OVER-THE-WIRE) (P950020/S079) | Boston Scientific Corp | 2017-02-09 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE) (P130030/S035) | Boston Scientific Corp | 2017-02-09 |
| INTELLANAV XP TEMPERATURE ABLATION CATHETERS (P020025/S094) | Boston Scientific | 2017-02-09 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S063) | Boston Scientific Corp | 2017-02-08 |
| VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S065) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-02-08 |
| IPERIA 7 VR-T/INVENTRA 7 VR-T (DF-1); IPERIA 7 VR-T/INVENTRA 7 VR-T (DF4) (P050023/S101) | Biotronik, Inc. | 2017-02-08 |
| PHYLAX AV ICD SYSTEM (P000009/S067) | Biotronik, Inc. | 2017-02-08 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S164) | Biotronik, Inc. | 2017-02-08 |
| T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (P140015/S019) | Tandem Diabetes Care, Inc. | 2017-02-08 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S074) | Biotronik, Inc. | 2017-02-08 |
| LINOX SMART/PROTEGO (ProMRI) S 65;LINOX SMART/PROTEGO (ProMRI) S 75;LINOX SMART/PROTEGO (ProMRI) SD 65/16;LINOX SMART/PR (P980023/S076) | Biotronik, Inc. | 2017-02-08 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S086) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-02-08 |
| ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A (P000037/S048) | On-X Life Technologies, Inc. | 2017-02-07 |
| ALGOVITA SPINAL CORD STIMULATION SYSTEM (P130028/S013) | Nuvectra Corporation | 2017-02-07 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S487) | Medtronic, Inc. | 2017-02-07 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S056) | Medtronic, Inc. | 2017-02-07 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S319) | Medtronic, Inc. | 2017-02-07 |
| LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S031) | Lenstec, Inc. | 2017-02-07 |
| MEDTRONIC FREESTYLE BIOPROSTHESIS (P970031/S054) | Medtronic, Inc. | 2017-02-07 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S014) | Medtronic, Inc. | 2017-02-07 |
| LUTONIX 035 DRUG COATED BALLOON PTA CATHETER (P130024/S009) | Lutonix | 2017-02-07 |
| RESTORE ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S352) | Medtronic Neuromodulation | 2017-02-07 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S617) | Medtronic Cardiac Rhythm Disease Management | 2017-02-07 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S246) | Medtronic, Inc. | 2017-02-07 |
| MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE (P990064/S065) | Medtronic, Inc. | 2017-02-07 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S576) | Medtronic Cardiac Rhythm Disease Management | 2017-02-07 |
| AMPLATZER PFO OCCLUDER (P120021/S001) | ABBOTT MEDICAL | 2017-02-06 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM SNS BOWEL LEADS (P080025/S132) | Medtronic Neuromodulation | 2017-02-06 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S270) | Medtronic, Inc. | 2017-02-06 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM DBS LEADS (P970004/S237) | Medtronic Neuromodulation | 2017-02-06 |
| RESTORE ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES, SPECIFY AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S351) | Medtronic Neuromodulation | 2017-02-06 |
| LGW (P010032/S127) | ABBOTT MEDICAL | 2017-02-03 |
| TRIFECTA VALVE, VALVE WITH GLIDE (P100029/S024) | ABBOTT MEDICAL | 2017-02-03 |
| MHY (P140009/S022) | ABBOTT MEDICAL | 2017-02-03 |
| PMP (P150004/S006) | ABBOTT MEDICAL | 2017-02-03 |
| SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE (P040021/S030) | ABBOTT MEDICAL | 2017-02-03 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S035) | Boston Scientific Corp | 2017-02-03 |
| ENDURANT & ENDURANT II STENT GRAFT SYSTEM; ENDURANT II AORTO-UNI-LIAC (AUI) STENT GRAFT SYSTEM; ENDURANT IIs STENT GRAFT (P100021/S060) | Medtronic Vascular | 2017-02-03 |
| POLYMACON SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S055) | CooperVision, Inc. | 2017-02-03 |
| COMFILCON A SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S053) | CooperVision, Inc. | 2017-02-03 |
| OCUFILCON D SOFT ( HYDROPHILIC) CONTACT LENSES (P890023/S026) | The Cooper Companies | 2017-02-03 |
| MASTERS VALVED GRAFT WITH HEMASHIELD GRAFT TECHNOLOGY (P810002/S100) | ABBOTT MEDICAL | 2017-02-02 |
| MiniMed 670G System (P160017/S003) | Medtronic Minimed, Inc. | 2017-02-02 |
| AMPLIA MRI CRT-D, AMPLIA MRI QUAD CRT-D, BRAVA CRT-D, BRAVA QUAD CRT-D, CLARIA MRI CRT-D, CLARIA MRI QUAD CRT-D, COMPIA (P010031/S570) | Medtronic Cardiac Rhythm Disease Management | 2017-02-02 |
| EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC (P980016/S610) | Medtronic Cardiac Rhythm Disease Management | 2017-02-02 |
| BIOFINITY SPHERE AND BIOFINITY XR SPHERE (P080011/S054) | CooperVision, Inc. | 2017-02-02 |
| ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM (P110011/S013) | Medtronic, Ireland | 2017-02-01 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S024) | Medtronic, Inc. | 2017-02-01 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P110013/S075) | Medtronic Vascular | 2017-02-01 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S089) | Medtronic, Ireland | 2017-02-01 |
| MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S194) | Medtronic, Inc. | 2017-02-01 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S048) | Medtronic Vascular | 2017-02-01 |
| ENDURANT/ENDURANT II/ ENDURANT IIS STENT GRAFT (P100021/S057) | Medtronic Vascular | 2017-02-01 |
| VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM (P100040/S028) | Medtronic Vascular | 2017-02-01 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S014) | Abbott Vascular (Idef Technologies Inc) | 2017-02-01 |
| COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA (P110040/S011) | Medtronic Vascular | 2017-02-01 |
| COMPLETE SE VASCULAR STENT SYSTEM– ILIAC (P090006/S019) | Medtronic Vascular | 2017-02-01 |
| COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE (P130023/S003) | Cohera Medical, Inc. | 2017-02-01 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033) | ABBOTT MEDICAL | 2017-01-31 |
| LWS, OSR (P910023/S378) | ABBOTT MEDICAL | 2017-01-31 |
| NIRXCELL COCR CORONARY STENT ON RX SYSTEM (P110004/S016) | Medinol, Ltd. | 2017-01-31 |
| PULSE GENERATOR, PACEMAKER, IMPLANTABLE WITH CARDIAC RESYNCHRONIZATION (CRT-P) (P070008/S080) | Biotronik, Inc. | 2017-01-31 |
| ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-PS (P030035/S151) | ABBOTT MEDICAL | 2017-01-31 |
| Promote/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA (P030054/S316) | ABBOTT MEDICAL | 2017-01-31 |
| ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S276) | ABBOTT MEDICAL | 2017-01-31 |
| DEFIBRILLATOR, IMPLANTABLE, DUAL CHAMBER, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION (P050023/S106) | Biotronik, Inc. | 2017-01-31 |
| IMPELLA 2.5 SYSTEM (P140003/S013) | Abiomed, Inc. | 2017-01-31 |
| PULSE GENERATOR, PERMANENT, IMPLANTABLE (P950037/S172) | Biotronik, Inc. | 2017-01-31 |
| BRACANALYSIS CDX (P140020/S008) | Myriad Genetic Laboratories | 2017-01-30 |
| PROPEL SINUS IMPLANT & PROPEL MINI SINUS IMPLANT (P100044/S026) | Intersect Ent. | 2017-01-27 |
| GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS (P160021) | W. L. Gore & Associates, Inc. | 2017-01-27 |
| IN PACT ADMIRAL PACLITAXEL BALLOON CATHETER (P140010/S028) | Medtronic, Inc. | 2017-01-26 |
| MEDTRONIC INTERSTIM THERAPY SYSTEM (URINARY) (P970004/S236) | Medtronic Neuromodulation | 2017-01-26 |
| FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C (P010059/S006) | Morcher GmbH | 2017-01-26 |