PMA P030005S087

Device
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S087
Product code
NKE
Decision date
2012-10-05
Classification
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement
CLEANING TOOL AID FOR THE SEALER HEATING PLATES.

Current openFDA PMA Record#

Device
CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S087
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date
2012-10-05
Decision code
OK30
Date received
2012-09-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CLEANING TOOL AID FOR THE SEALER HEATING PLATES.