PMA P880086S218

Device
PACEMAKER FAMILY OF DEVICES (INTEGRITY, IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, ACCENT FAMILY OF DEVICES)
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S218
Product code
NVZ
Decision date
2012-05-03
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.

Current openFDA PMA Record#

Device
PACEMAKER FAMILY OF DEVICES (INTEGRITY, IDENTITY, VERITY, SUSTAIN, VICTORY, ZEPHYR, ACCENT FAMILY OF DEVICES)
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S218
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2012-05-03
Decision code
OK30
Date received
2012-04-03
Supplement type
30-Day Notice
Approval order statement
IMPLEMENT ST. JUDE MEDICAL DISTRIBUTION AND LABELING SYSTEM (SDLS) FOR ALL SJM CRMD PRODUCTS.