| QuickFlex and Quartet Leads (P030054/S312) | ABBOTT MEDICAL | 2016-11-06 |
| Durata and Optisure Leads (P950022/S096) | ABBOTT MEDICAL | 2016-11-06 |
| TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (P960013/S086) | ABBOTT MEDICAL | 2016-11-06 |
| ANIMAS VIBE SYSTEM (P130007/S019) | Animas Corp. | 2016-11-05 |
| ANIMAS VIBE SYSTEM (P130007/S022) | Animas Corp. | 2016-11-05 |
| Oxford Partial Knee System (P010014/S059) | Biomet Manufacturing Corp | 2016-11-04 |
| AspireAssist (P150024/S004) | Aspire Bariatrics, Inc. | 2016-11-04 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA2 PACEMAKER MODELS (N970003/S196) | Boston Scientific Corp | 2016-11-03 |
| BIOFINITY ENERGYS (P080011/S050) | CooperVision, Inc. | 2016-11-03 |
| VALITUDE CRT-P (P030005/S144) | Guidant Corp. | 2016-11-03 |
| IMPELLA CP SYSTEM (P140003/S011) | Abiomed, Inc. | 2016-11-03 |
| LifeVest Device (P010030/S085) | Zoll Manufacturing Corporation | 2016-11-03 |
| CyPass System (P150037/S001) | Alcon Research, Ltd. | 2016-11-03 |
| ESSENTIO, PROPONENT, ACCOLADE MRI PACEMAKERS (P150012/S017) | Boston Scientific | 2016-11-03 |
| CAPSURE EPICARDIAL PACING LEAD (P950024/S069) | Medtronic, Inc. | 2016-11-02 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S084) | Medtronic | 2016-11-02 |
| ADHESIVE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS+ LEADS (P830061/S136) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| DF-1 CONNECTOR PORT PIN PLUG/IS-1 CONNECTOR PORT PIN PLUG KIT/SPRINT QUATTRO/SUBCUTANEOUS/TRANSVENCE CS/SVC LEADS (P920015/S186) | Medtronic, Inc. | 2016-11-02 |
| ATTAIN BIPOLAR OTW AND OTE LV LEAD (P010015/S312) | Medtronic, Inc. | 2016-11-02 |
| Evera S DR,VR ICD; Evera XT DR, VR ICD (P980016/S605) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| CAPSURE VDD 2/SERVICE KIT-PACEMAKER REPAIR KIT/VITATRON BRILLLIANT S+ VDD LEAD (P890003/S366) | Medtronic, Inc. | 2016-11-02 |
| END CAP/UPSIZING SLEEVE (P900061/S143) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| ATTAIN ABILITY/PERFORMA LEAD (P080006/S100) | Medtronic, Inc. | 2016-11-02 |
| ANCHORING SLEEVE KIT/SELECTSECURE LEAD (P030036/S087) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| HEARTWARE VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S085) | Medtronic | 2016-11-02 |
| TRANSVENE CS/SVC LEAD (P980050/S107) | Medtronic, Inc. | 2016-11-02 |
| CAPSUREFIX/CAPSUREFIX NOVUS/VITATRON CRYSTALLINE ACTIVE FIXATION LEADS (P930039/S161) | Medtronic, Inc. | 2016-11-02 |
| CAPSURE SP NOVUS/CAPSURE SP Z/CAPSURE Z NOVUS/VITATRON IMPULSE II LEADS (P850089/S120) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN (P130018/S001) | Uromedica, Inc. | 2016-11-02 |
| ATTAIN STARFIX LEAD (P060039/S074) | Medtronic, Inc. | 2016-11-02 |
| Micra TPS MC1VR01 (P150033/S010) | Medtronic, Inc. | 2016-11-02 |
| Brava,Brava Quad CRT-D; Viva S, XT,Viva Quad S, XT CRT-D (P010031/S566) | Medtronic Cardiac Rhythm Disease Management | 2016-11-02 |
| CAPSUREFIX MRI LEAD (P090013/S238) | Medtronic, Inc. | 2016-11-02 |
| MYOCARDIAL PACING LEAD (P120017/S006) | Medtronic, Inc. | 2016-11-02 |
| WALLSTENT ENDOPROSTHESIS VENOUS (P980033/S047) | Boston Scientific Corporation | 2016-11-01 |
| EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S038) | Boston Scientific Corp | 2016-11-01 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) (P110042/S066) | Boston Scientific Corporation | 2016-11-01 |
| CARTIVA SYNTHETIC CARTILAGE IMPLANT (P150017/S003) | Cartiva, Inc. | 2016-11-01 |
| AMS 800 URINARY CONTROL SYSTEMS & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT (P000053/S070) | Boston Scientific Corp | 2016-11-01 |
| Restylane, Perlane, Restylane Lyft (formerly Perlane-L), Restylane Silk (P040024/S093) | Q-Med AB | 2016-11-01 |
| WALLSTENT ENDOPROSTHESIS TIPS (P930031/S058) | Boston Scientific Corp | 2016-11-01 |
| WALLSTENT ENDOPROSTHESIS ILIAC (P940019/S049) | Boston Scientific Scimed, Inc. | 2016-11-01 |
| INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S019) | Boston Scientific Corporation | 2016-11-01 |
| COBAS HBV TEST (P150014/S004) | Roche Molecular Systems, Inc. | 2016-10-31 |
| COBAS HCV TEST (P150015/S004) | Roche Molecular Systems, Inc. | 2016-10-31 |
| COBAS HBV TEST (P150014/S005) | Roche Molecular Systems, Inc. | 2016-10-31 |
| IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (P140010/S018) | Medtronic, Inc. | 2016-10-31 |
| AMPLATZER PFO OCCLUDER (P120021) | ABBOTT MEDICAL | 2016-10-28 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S019) | Cochlear Americas | 2016-10-28 |
| NEW BRANSON ULTRASONIC WELDER GENII (P860057/S147) | Edwards Lifesciences, LLC | 2016-10-28 |
| InSightec ExAblate System (P040003/S019) | Insightec, Ltd. | 2016-10-28 |
| LIFESTENT VASCULAR STENT SYSTEM (P070014/S052) | Bard Peripheral Vascular, Inc. | 2016-10-28 |
| PROPEL SINUS, MINI SINUS IMPLANT. (P100044/S025) | Intersect Ent. | 2016-10-28 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S147) | Cochlear Americas | 2016-10-28 |
| PROPEL, PROPEL MINI SINUS IMPLANT (P100044/S024) | Intersect Ent. | 2016-10-28 |
| ABBOTT ARCHITECT AFP ASSAY (P120008/S010) | Abbott Laboratories | 2016-10-27 |
| VISTAKON (SENOFILCON A) BAND CONTACT LENS, (P040045/S060) | Vistakon, Division of Johnson & Johnson Vision Car | 2016-10-27 |
| The ThermoCool SmartTouch SF Uni-Directional & Bi-Directional Navigational Catheter (P030031/S078) | Biosense Webster, Inc. | 2016-10-27 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S260) | Boston Scientific Corp | 2016-10-26 |
| THINPREP PROCESSOR, (P950039/S035) | Hologic, Inc. | 2016-10-26 |
| GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S025) | ETHICON, Inc. | 2016-10-26 |
| DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S053) | Dexcom, Inc. | 2016-10-26 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S012) | Cardiovascular Systems, Inc. | 2016-10-26 |
| Precision, Precision Spectra, Precision Novi, Precision Montage and Precision Montage MRI Spinal Cord Stimulator (SCS) S (P030017/S261) | Boston Scientific Corp | 2016-10-26 |
| RADIESSE Injectable Implant; RADIESSE (+) Lidocaine Dermal Filler (P050052/S084) | Merz North America, Inc. | 2016-10-26 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S008) | Medtronic, Inc. | 2016-10-26 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S022) | Boston Scientific Corporation | 2016-10-26 |
| QuickFlex U (P030054/S310) | ABBOTT MEDICAL | 2016-10-26 |
| RADIESSE Injectable Implant (P050037/S072) | Merz North America, Inc. | 2016-10-26 |
| ADVIA CENTAUR HBSAGII (HBSII);ADVIA CENTAUR XP HBSAG CONFIRMATORY (P110041/S003) | Siemens Corp. | 2016-10-26 |
| Medtronic CoreValve Evolut R XL system (P130021/S025) | Medtronic, Inc. | 2016-10-26 |
| RESTYLANE INJECTABLE GEL (P040024/S092) | Q-Med AB | 2016-10-25 |
| SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S042) | ETHICON, Inc. | 2016-10-25 |
| RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S005) | Boston Scientific Corporation | 2016-10-25 |
| CARELINK MONITOR MODEL 2490C, MODEL 24950; CARDIOSIGHT READER MODEL 2020A, CARELINK EXPRESS MONITOR 2020B, MODEL 2491 DD (P890003/S356) | Medtronic, Inc. | 2016-10-25 |
| CAPSURE SENSE MRI SURESCAN LEAD MODEL 4574 (P830061/S130) | Medtronic Cardiac Rhythm Disease Management | 2016-10-25 |
| CLARIA MRI CRT-D SURESCAN MODEL DTMA1D4; QUAD MODEL DTMA1QQ; MODEL DTMA1D1, MODEL DTMBIQ1, MODEL DTMB1Q1,MODEL DTMC1D1, (P010031/S550) | Medtronic Cardiac Rhythm Disease Management | 2016-10-25 |
| MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD; ATTAIN ABILITY PLUS MRI SURESCAN LEAD MODEL 4296; ATTAIN ABILITY STRAIGHT MRI (P080006/S093) | Medtronic, Inc. | 2016-10-25 |
| MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 (P930039/S152) | Medtronic, Inc. | 2016-10-25 |
| CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI (P090013/S226) | Medtronic, Inc. | 2016-10-25 |
| GORE VIABAHN ENDOPROSTHESIS and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S094) | W. L. Gore & Associates, Inc. | 2016-10-25 |
| Gore CARDIOFORM Septal Occluder (P050006/S053) | W. L. Gore & Associates, Inc. | 2016-10-25 |
| SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935M & 6935; SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947M & 6947 (P920015/S179) | Medtronic, Inc. | 2016-10-25 |
| Repy SR/DR & Esprit SR/DR Pacemakers (P950029/S112) | MicroPort CRM USA, Inc. | 2016-10-25 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S033) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| Amplia MRI CRT-D & QUAD CRT-D, Brava CRT-D, Brava Quad CRT-D, Compia MRI CRT-D & MRI Quad CRT-D, Viva Quad S & XT CRT-D' (P010031/S564) | Medtronic Cardiac Rhythm Disease Management | 2016-10-24 |
| INTERSTIM THERAPY SYSTEM FOR BOWEL CONTROL (P080025/S124) | Medtronic Neuromodulation | 2016-10-24 |
| ADVIA CENTAUR CPSA ASSAY (P990055/S015) | Siemens Healthcare Diagnostics | 2016-10-24 |
| Adapta, Verds, Sensia IPG ; Advisa DR IPG; Advisa DR & SR MRI IPG; Relia IPG (P980035/S476) | Medtronic, Inc. | 2016-10-24 |
| Evera MRI, S DR, S VR, XT DR, XT VR ICD's; Visia AF MRI VR ICD & Visia AF VR ICD (P980016/S603) | Medtronic Cardiac Rhythm Disease Management | 2016-10-24 |
| Micra TPS (P150033/S007) | Medtronic, Inc. | 2016-10-24 |
| ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG (P130015/S007) | Roche Diagnostics Operations, Inc. | 2016-10-24 |
| Consulta CRT0P, Syncra CRT-P, Viva CRT-P (P010015/S310) | Medtronic, Inc. | 2016-10-24 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S087) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| SURGICEL FAMILY OF ABSORBABLE HEMOSTATS (N12159/S041) | ETHICON, Inc. | 2016-10-24 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S138) | W. L. Gore & Associates, Inc. | 2016-10-24 |
| PD-L1 IHC 22C3 PHARMDX (P150013/S001) | Agilent Technologies, Inc. | 2016-10-24 |
| Reno MRI SureScan IPG (P090013/S237) | Medtronic, Inc. | 2016-10-24 |
| GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S022) | ETHICON, Inc. | 2016-10-24 |
| Amplia MRI CRT-D & Quad CRT-D, Brava CRT-D & Quad CRT-D, Compia MRI CRT-D & Quad CRT-D, Concerto II CRT-D, Consulta CRT- (P010031/S562) | Medtronic Cardiac Rhythm Disease Management | 2016-10-24 |