PMA P880086S203

Device
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S203
Product code
LWP
Decision date
2011-08-03
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.

Current openFDA PMA Record#

Device
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S203
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2011-08-03
Decision code
APPR
Date received
2011-05-02
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODEL 3330 PROGRAMMER SOFTWARE VERSION 10.1.2, WHICH INCLUDES MINOR MODIFICATIONS TO THE PACING LEAD IMPEDANCE FEATURE.