Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO/EVO+VISIAN Implantable Collamer Lens

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO/EVO+ VISIAN® Implantable Collamer® Lenses

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO/EVO+ VISIAN® Implantable Collamer® Lenses

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF FAMILY OF CRT-DS

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta, Syncra and Viva CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG, Advisa DDR MRI IPG and Advisa SR MRI IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (QVD)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AND CONTAK CD FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AND CONTAK CD FAMILIES OF ICDS

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·Visian ICL (Implantable Collamer Lens), Visian Toric ICL (Implantable Collamer Lens), Visian EVO/EVO+ ICL (Implantable C

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating