PMA P880086S282

Device
Accent, Identity, Verity, Victory And Zephyr Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S282
Product code
DXY
Decision date
2017-05-05
Classification
Implantable Pacemaker Pulse-generator
Generic name
implantable pacemaker Pulse-generator
Approval order statement
Longer dwell time between plasma cleaning and wire bonding of the hybrid.

Current openFDA PMA Record#

Device
Accent, Identity, Verity, Victory And Zephyr Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S282
Product code
DXY
Generic name
implantable pacemaker Pulse-generator
Decision date
2017-05-05
Decision code
OK30
Date received
2017-04-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Longer dwell time between plasma cleaning and wire bonding of the hybrid.