Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Heart System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODELS 940 & 941 VISTA DDD GEN. & MODEL 2050 MODUL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 446 & 447 VISTA T,MODEL 940 & 941 VISTA DDD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 446 & 447 VISTA T,MODEL 940 & 941 VISTA DDD

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS