Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 DEVICES: ORIGEN, INOGEN, DYNAGEN ICDS; PROGENY DEVICES: PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBA VISION (VASURFILCON A) SOFT CONTACT LENSES

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·DIOMED 630 PDT LASER

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·PHOTOFRIN 630 PDT Laser

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·PHOTOFRIN 630 PDT Laser

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·PHOTOFRIN 630 PDT LASER

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·DIOMED 630 PDT LASER

Gonococcal Antibody Tests

FDA Pre-Market Approval

FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·VISULAS 690S AND VISULINK PDT/U ADAPTER

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·VISULAS 690S LASER AND VISULINK PDT ADAPTER

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPG/C-SERIES IPG/T-SERIES IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPG; C-SERIES IPG; T-SERIES IPG

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER

MODEL 430-07 ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

FDA 510(k)

FDA Class 3 ·Cardiovascular