PMA P880086S157

Device
AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S157
Product code
NVZ
Decision date
2007-12-11
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
ALTERNATE PROCESS FOR ADHERING THE HYBRID SUBSTRATE TO THE HYBRID SUPPORT.

Current openFDA PMA Record#

Device
AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S157
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2007-12-11
Decision code
OK30
Date received
2007-11-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE PROCESS FOR ADHERING THE HYBRID SUBSTRATE TO THE HYBRID SUPPORT.