PMA P880086S245

Device
AFFINITY, INTEGRITY, VICTORY, ZEPHYR, & ACCENT FAMILY OF PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S245
Product code
NVZ
Decision date
2014-09-12
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
APPROVAL FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1.

Current openFDA PMA Record#

Device
AFFINITY, INTEGRITY, VICTORY, ZEPHYR, & ACCENT FAMILY OF PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S245
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2014-09-12
Decision code
APPR
Date received
2014-07-02
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER SOFTWARE MODEL 3330 VERSION 19.1.