PMA P880086S248

Device
ENDURITY FAMILY OF PACEMEKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S248
Product code
LWP
Decision date
2014-12-22
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
APPROVAL FOR THE ADDITION OF NON-FUNCTIONAL JUMPER CONNECTIONS FOR THE HYBRID ASSEMBLIES UTILIZED IN THE DEVICES.

Current openFDA PMA Record#

Device
ENDURITY FAMILY OF PACEMEKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S248
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2014-12-22
Decision code
APPR
Date received
2014-10-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE ADDITION OF NON-FUNCTIONAL JUMPER CONNECTIONS FOR THE HYBRID ASSEMBLIES UTILIZED IN THE DEVICES.