PMA P880086S145

Device: AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S145
Product code: NVZ
Decision date: 2007-05-09
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.

Current openFDA PMA Record#

Device: AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S145
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2007-05-09
Decision code: APPR
Date received: 2007-04-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.