PMA P880086S161

Device: IDENTITY, INTEGRITY, VERITY, VICTORY, AND ZEPHYR FAMILIES OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S161
Product code: NVZ
Decision date: 2008-04-04
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, CAGUAS, PUERTO RICO, FOR FINAL MANUFACTURING OPERATIONS, EXCLUDING STERILIZATION.

Current openFDA PMA Record#

Device: IDENTITY, INTEGRITY, VERITY, VICTORY, AND ZEPHYR FAMILIES OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S161
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2008-04-04
Decision code: APPR
Date received: 2008-02-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ST. JUDE MEDICAL PUERTO RICO, CAGUAS, PUERTO RICO, FOR FINAL MANUFACTURING OPERATIONS, EXCLUDING STERILIZATION.