| ST JUDE MEDICAL TRIFECTA VALVE (P100029/S023) | ABBOTT MEDICAL | 2016-12-30 |
| BIOFINITY XR Toric (P080011/S052) | CooperVision, Inc. | 2016-12-29 |
| SENZA SPINAL CORD STIMULATION (SCS) SYSTEM (P130022/S010) | Nevro Corporation | 2016-12-28 |
| NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S036) | Allergan | 2016-12-28 |
| ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S020) | Cook Ireland, Ltd. | 2016-12-28 |
| MINIMED 530G SYSTEM (P120010/S099) | Medtronic, Inc. | 2016-12-27 |
| REVISION OPTICS RAINDROP NEAR VISION INLAY (P150034/S001) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2016-12-27 |
| IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S004) | Medtronic Minimed | 2016-12-27 |
| SofLens (polymacon) Visibility Tinted Contact Lens (N16895/S099) | Bausch & Lomb, Inc. | 2016-12-27 |
| MiniMed 670G System (P160017/S006) | Medtronic Minimed, Inc. | 2016-12-27 |
| MINIMED 630G SYSTEM WITH SMARTGUARD (P150001/S006) | Medtronic Minimed | 2016-12-27 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S026) | Medtronic Minimed | 2016-12-27 |
| ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS (P030040/S011) | Siemens Healthcare Diagnostics | 2016-12-25 |
| Blazer II, Blazer II HTD, Blazer Prime HTD (P920047/S095) | Boston Scientific Corp | 2016-12-23 |
| Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II (P160019) | Roche Diagnostics, Inc. | 2016-12-23 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S058) | Abbott Vascular | 2016-12-23 |
| ABBOTT REALTIME HCV (P100017/S019) | Abbott Molecular, Inc. | 2016-12-23 |
| LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S030) | Bunnell, Inc. | 2016-12-23 |
| ABBOTT REALTIME HBV ASSAY (P080026/S020) | Abbott Molecular, Inc. | 2016-12-23 |
| Blazer II XP; Blazer Prime XP (P020025/S093) | Boston Scientific | 2016-12-23 |
| ABBOTT REALTIME HCV GENOTYPE II (P120012/S015) | Abbott Molecular | 2016-12-23 |
| AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S125) | Boston Scientific Corp | 2016-12-22 |
| PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N (P830063/S009) | Vantive US Healthcare, LLC | 2016-12-22 |
| ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS (P040020/S049) | Alcon Research, Ltd. | 2016-12-22 |
| CARDIOMEMS HF SYSTEM (P100045/S016) | ABBOTT MEDICAL | 2016-12-22 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S074) | Boston Scientific Corp | 2016-12-22 |
| MAESTRO RECHARGEABLE SYSTEM (P130019/S012) | Reshape Lifesciences, Inc. | 2016-12-22 |
| Pressure Sensing Lead (P130008/S018) | Inspire Medical Systems | 2016-12-22 |
| IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM, NG2.5, DYNAGEN, INOGEN, ORIGEN MINI ICD's (P960040/S383) | Boston Scientific | 2016-12-22 |
| INTERSTIM THERAPY SYSTEM (P970004/S233) | Medtronic Neuromodulation | 2016-12-22 |
| ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S267) | Medtronic, Inc. | 2016-12-22 |
| ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S348) | Medtronic Neuromodulation | 2016-12-22 |
| MiniMed 670G System (P160017/S004) | Medtronic Minimed, Inc. | 2016-12-22 |
| INTERSTIM THERAPY SYSTEM (P080025/S128) | Medtronic Neuromodulation | 2016-12-22 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM OVER THE WIRE (OTW) (P130030/S034) | Boston Scientific Corp | 2016-12-21 |
| NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S017) | Cochlear Americas | 2016-12-21 |
| Adapta, Versa, Sensia IPG & Relia IPG (P980035/S478) | Medtronic, Inc. | 2016-12-21 |
| VENTANA PD-L1(SP142) CDX ASSAY (P160002/S001) | Ventana Medical Systems, Inc. | 2016-12-21 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) AND AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE (N970012/S123) | Boston Scientific Corp | 2016-12-21 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S001) | Smith & Nephew, Inc. | 2016-12-21 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S141) | W. L. Gore & Associates, Inc. | 2016-12-21 |
| ACUITY X4 lead family shelf life (P010012/S437) | Boston Scientific Corp | 2016-12-21 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S153) | Cochlear Americas | 2016-12-21 |
| NUCLEUS AUDITORY BRAINSTEM IMPLANT (P000015/S018) | Cochlear Americas | 2016-12-21 |
| BIRMINGHAM HIP SYSTEM (BHR) (P040033/S030) | Smith & Nephew, Inc. | 2016-12-21 |
| CORMET HIP RESURFACING SYSTEM (P050016/S011) | Corin USA | 2016-12-21 |
| REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S038) | Smith & Nephew, Inc. | 2016-12-21 |
| LifeVest Wearable Defibrillator (P010030/S084) | Zoll Manufacturing Corporation | 2016-12-21 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S154) | Cochlear Americas | 2016-12-21 |
| MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM (P860004/S264) | Medtronic, Inc. | 2016-12-20 |
| MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S016) | Mentor Worldwide, LLC | 2016-12-20 |
| DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S041) | Dexcom, Inc. | 2016-12-20 |
| IMPLANTABLE MINIATURE TELESCOPE (IMT) (P050034/S016) | Samsara Vision, Inc. | 2016-12-20 |
| MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM (P000025/S091) | Med-El Corp. | 2016-12-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S140) | W. L. Gore & Associates, Inc. | 2016-12-20 |
| COBAS HCV (P150015/S005) | Roche Molecular Systems, Inc. | 2016-12-19 |
| CAPSURE VDD 2 LEAD/ VITATRON BRILLIANT S+VDD LEAD (P890003/S370) | Medtronic, Inc. | 2016-12-19 |
| AMPLIA MRI CRT-D & QUAD CRT-D; BRAVA CRT-D & QUAD CRT-D; CLARIA MRI CRT-D & QUAD CRT-D; COMPIA MRI CRT-D & QUAD CRT-D ; (P010031/S574) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| CAPSURE SENSE LEAD /SP LEAD / CAPSURE SP NOVUS LEAD/ VITATRON CRYSTALLINE LEAD/ VITATRON EXCELLENCE PS + LEAD (P830061/S139) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS & XIENCE NANO EECSS (P070015/S135) | Abbott Vascular, Inc. | 2016-12-19 |
| PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM (P960043/S095) | Abbott Vascular, Inc. | 2016-12-19 |
| Attain Bipolar OTW Lead & Attain OTW LV Lead (P010015/S316) | Medtronic, Inc. | 2016-12-19 |
| EVERA MRI ICD/ S DR/ S VR/ XT DR / XTVR ICD; MAXIMO II ICD ; VIVA QUAD XT CRT-D; VIVA S CRT-D; VIVA XT CRT-D (P980016/S614) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| SELECTSECURE LEAD (P030036/S090) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| CAPSURE SP NOVUS LEAD / Z LEAD ; CAPSURE Z NOVUS LEAD ; VITATRON IMPLUSE II LEAD (P850089/S122) | Medtronic Cardiac Rhythm Disease Management | 2016-12-19 |
| GEL-ONE (P080020/S023) | Seikagaku Corp. | 2016-12-19 |
| AMS 700 INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE TREATMENT (N970012/S122) | Boston Scientific Corp | 2016-12-19 |
| STARCLOSE VASCULAR CLOSURE SYSTEM (P050007/S034) | Abbott Vascular Devices | 2016-12-19 |
| TRIDYNE VASCULAR SEALANT, TRIDYNE EXTENDED APPLICATOR SPRAY TIP. (P150016/S002) | Neomend, Inc. | 2016-12-19 |
| CapSure Epicardial Pacing Lead (P950024/S071) | Medtronic, Inc. | 2016-12-19 |
| HV SPLITTER/ADAPTOR KIT; SPRINT QUATTRO LEAD; SUBCUTANEOUS LEAD ; TRANSVENE CS/SVC LEAD (P920015/S190) | Medtronic, Inc. | 2016-12-19 |
| COBAS HBV (P150014/S006) | Roche Molecular Systems, Inc. | 2016-12-19 |
| Protego TD 75/18, 65/18, 65/16; T 65; SD 75/18, 65/18, 65/16, 60/16, S75, S65, S60; Protego DF-1 TD 75/18, 65/18, 65/16; (P980023/S079) | Biotronik, Inc. | 2016-12-19 |
| GUARDIAN LINK TRANSMITTER (P160017/S007) | Medtronic Minimed, Inc. | 2016-12-19 |
| GURADIAN LINK TRANSMITTER (P150001/S005) | Medtronic Minimed | 2016-12-19 |
| CAPSUREFIX LEAD; CAPSUREFIX NOVUS LEAD; VITATRON CRYSTALLINE ACTIVE FIXATION LEAD (P930039/S164) | Medtronic, Inc. | 2016-12-19 |
| ATTAIN STARFIX LEAD (P060039/S076) | Medtronic, Inc. | 2016-12-19 |
| ATTAIN ABILITY LEAD & ATTAIN PERFORMA LEAD (P080006/S104) | Medtronic, Inc. | 2016-12-19 |
| FoundationFocus CDxBRCA (P160018) | Foundation Medicine, Inc. | 2016-12-19 |
| ELLIPSE (P910023/S377) | ABBOTT MEDICAL | 2016-12-19 |
| SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) (P110042/S071) | Boston Scientific Corporation | 2016-12-19 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S156) | Boston Scientific Corp | 2016-12-19 |
| XIENCE PRIME /XIENCE XPEDITION /ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S088) | Abbott Vascular | 2016-12-19 |
| Linox smart TD 75/18/ 65/18/ 65/16; Linox smart SD 75/18/ 65/18/ 65/16 60/16; Linox smart T65/ S75/ D65/S60; Linox smart (P950037/S170) | Biotronik, Inc. | 2016-12-19 |
| ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678 (P010012/S440) | Boston Scientific Corp | 2016-12-19 |
| MINILINK REAL TIME TRANSMITTER (P150019/S025) | Medtronic Minimed | 2016-12-19 |
| MINILINK REAL TIME TRANSMITTER (P980022/S197) | Medtronic Minimed | 2016-12-19 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S072) | Boston Scientific Corp | 2016-12-19 |
| IPRO2 RECORDER (P150029/S003) | Medtronic Minimed | 2016-12-19 |
| INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S022) | Boston Scientific Corporation | 2016-12-19 |
| MINIMED 530G SYSTEM (P120010/S098) | Medtronic, Inc. | 2016-12-19 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S027) | Medtronic, Inc. | 2016-12-18 |
| OneTouch Vibe Plus System (P130007/S016) | Animas Corp. | 2016-12-16 |
| JUVEDERM VOLUMA XC & VOLBELLA XC (P110033/S024) | Allergan | 2016-12-16 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM CLINICIAN PROGRAMMER (P080012/S037) | Infusyn Therapeutics, LLC | 2016-12-16 |
| GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S036) | W. L. Gore & Associates, Inc. | 2016-12-16 |
| PMA NIT-OCCLUD PDA (P120009/S003) | Pfm Medical, Inc. | 2016-12-16 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S027) | Boston Scientific Corporation | 2016-12-16 |
| VIABAHN ENDOPROSTHESIS (P040037/S097) | W. L. Gore & Associates, Inc. | 2016-12-16 |
| Reply/Esprit Pacemakers Sorin CRM. (P950029/S113) | MicroPort CRM USA, Inc. | 2016-12-16 |