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

FDA Pre-Market Approval

FDA Class 3 ·ELA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ELA MEDICAL'S REPLY PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ELA RATE-RESPONSIVE PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ELA RATE-RESPONSIVE PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY & ELA RHAPSODY DEVICES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY & ELA RHAPSODY PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ELA MEDICAL RATE-RESPONSIVE PACEMAKERS

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·DIMENSIONS TPSA FLE REAGENT CARTRIDGE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY AND ELA RHAPSODY PACEMAKERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ELA MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY & ELA RHAPSODY PACEMAKERS

COAXIAL BALLOON URETHRAL DILATOR

FDA 510(k)

FDA Class 3 ·Unknown

ELA MEDICAL UNILITH 7540 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS MODEL 4001

FDA 510(k)

FDA Class 3 ·Cardiovascular

FOCUS J81F, J83F, J41F, J43F PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA MODEL UJ45 PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACING LEAD #PMA F 860

FDA 510(k)

FDA Class 3 ·Cardiovascular