PMA P880086S155

Device: ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, AND ZEPHYR PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S155
Product code: NVZ
Decision date: 2008-05-16
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.

Current openFDA PMA Record#

Device: ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, AND ZEPHYR PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S155
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2008-05-16
Decision code: APPR
Date received: 2007-10-19
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 STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.