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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, CLaria MRI Quad CRT-D, Compia

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, Attain OTW LV Lead, COnsulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Subcutaneous Lead, and Tran

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS); PROGEL Spare Tips accessory; PROGEL 6 Extended Tips accessory; PROGEL 11 Extende

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Family of DBS IPGs

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Family of DRG IPGs

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Family of SCS IPGs

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G INSULIN PUMPS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS ANGIOPLASTY BALLOON CATHETER

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous-Transluminal Angioplasty Balloon Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER