PMA P880086S241

Device
ASSURITY, ASSURITY +, AND ENDURITY OF PACEMAKER DEVICES
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S241
Product code
NVZ
Decision date
2014-04-24
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
ALTERNATE FINAL ASSEMBLY MATERIAL FOR USE IN HYBRID ASSEMBLIES.

Current openFDA PMA Record#

Device
ASSURITY, ASSURITY +, AND ENDURITY OF PACEMAKER DEVICES
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S241
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2014-04-24
Decision code
OK30
Date received
2014-04-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE FINAL ASSEMBLY MATERIAL FOR USE IN HYBRID ASSEMBLIES.