PMA P880086S186

Device
FRONTIER/FRONTIER II FAMILY OF CRT-PS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S186
Product code
NVZ
Decision date
2010-04-23
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
CHANGE IN AUTOMATED MANUFACTURING TESTS.

Current openFDA PMA Record#

Device
FRONTIER/FRONTIER II FAMILY OF CRT-PS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S186
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2010-04-23
Decision code
OK30
Date received
2010-03-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN AUTOMATED MANUFACTURING TESTS.