Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILT OF PACEMAKERS

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·Linx Reflux Management System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DS CATHETER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PARAGON/PHOENIX FAMILY OF PACEMAKERS

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·DIAPHAGMATIC/PHRENIC NERVE STIMULATOR

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Aesculap activL Artificial Disc

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SURESTAT ARTERIAL CLOSURE SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA ST PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 7052

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·COMPLEXED PSA MICROTITER ELISA