PMA P880086S137

Device: AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S137
Product code: NVZ
Decision date: 2006-11-21
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: ELIMINATION OF THE EXTRA PERIMETER STAKING EPOXY AT FINAL ASSEMBLY ON THE LV HYBRID AND COVER SUPPORT INTERFACE ON ALL AFFINITY, INTEGRITY, IDENTITY, VICTORY AND FRONTIER FAMILY OF DEVICES.

Current openFDA PMA Record#

Device: AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S137
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2006-11-21
Decision code: OK30
Date received: 2006-10-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ELIMINATION OF THE EXTRA PERIMETER STAKING EPOXY AT FINAL ASSEMBLY ON THE LV HYBRID AND COVER SUPPORT INTERFACE ON ALL AFFINITY, INTEGRITY, IDENTITY, VICTORY AND FRONTIER FAMILY OF DEVICES.