Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE DEVICES & PROMOTE ACCEL DEVICES

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·VISIONCARE IMPLANTABLE MINIATURE TELESCOPE

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ReShape Integrated Dual Ballon System

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO SR/DR SL, PG PROPONENT SR/DR SL, DR EL, PG ACCOLADE SR/DR SL, DR EL, PG ALTRUA 2 SR/DR SL, DR EL

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Enticos 4 DR, Enticos 4 D, Enticos 4 SR, Enticos 4 S, Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6

Stimulator, Carotid Sinus Nerve

FDA classification

FDA Class 3 ·Stimulator, Carotid Sinus Nerve

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS DR,D,SR, AND S PULSE GENERATORS AND PMS 1000C PROGRAMMING AND MONITORING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

DJP UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

EKG TRANSMITTER MODEL 5134

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 1000S

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

EDP-20 PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

FDA 510(k)

FDA Class 3 ·Cardiovascular

DJ UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

CODEMASTER XL + XL W/SHOCK ADVISORY OPTION

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIOTRONIK PERMANENT PACEMAKER ELECTRODE

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