PMA P880086S231

Device: IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S231
Product code: NVZ
Decision date: 2013-04-23
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR THE USE OF A SECOND SOURCE SUPPLIER FOR ANCHORS USED IN THE FIRMS ICD, CRT-D, PACEMAKER, AND CRT-P DEVICES.

Current openFDA PMA Record#

Device: IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S231
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2013-04-23
Decision code: APPR
Date received: 2012-12-11
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE USE OF A SECOND SOURCE SUPPLIER FOR ANCHORS USED IN THE FIRMS ICD, CRT-D, PACEMAKER, AND CRT-P DEVICES.