PMA P880086S255

Device: AFFINITY/INTEGRITY / VICTORY /ZEPHYR ACCENT FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S255
Product code: NVZ
Decision date: 2015-08-27
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3 MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.

Current openFDA PMA Record#

Device: AFFINITY/INTEGRITY / VICTORY /ZEPHYR ACCENT FAMILY OF PACEMAKERS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S255
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2015-08-27
Decision code: APPR
Date received: 2015-02-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3 MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.