Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INDURA 1P ONE PIECE INTRATHECAL CATHETER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EN VISTA ONE PIECE HYDROPHOBIC ACRYLIC LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular Lens

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify® Cervical Artificial Disc (One-Level)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT DEVICE

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX® Ceramic Total Hip System

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE NEURO THALAMOTOMY

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Urinary Control

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG Essentio SR SL, PG Essentio DR SL, PG Essentio DR EL, PG Proponent SR SL, PG Proponent DR SL, PD Proponent DR EL, PG

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·PG Valitude CRT-P IS1 EL, PG Valitude CRT-P IS4 EL, PG Visionist CRT-P IS1 EL, PG Visionist CRT-P LV1 EL, PG Visionist C

Neuromodulator For Obesity

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Bowel Control

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CryoConsole

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG Essentio MRI SR SL, PG Essentio MRI DR SL, PG Essentio MRI DR EL, PG Proponent MRI SR SL, PG Proponent MRI DR EL, PG

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis (One-Level Indication)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System, Resilience Surgical Lead, Embrace One