Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, and Defibrillator, automatic

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 018 Drug Coated Balloon Catheter

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX AV ICD SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·XELOS DR-T ICD SYSTEM AND APPLICATION SOFTWARE VERSION A-K00.3.U

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·SELECTED MODELS OF DUAL CHAMBER ICD DEVICES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/...

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW UP STEROID-ELUTING LEAD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS AND CRT-DS

Neuromodulator For Obesity

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540

Neuromodulator For Obesity

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PROGRAMMABLE PUMP

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE CERVICAL DISC SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRODISC TM-C TOTAL DISC REPLACEMENT

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE® Cervical Disc

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·M6-C Artificial Cervical Disc