PMA P030005S043

Device
CONTAK RENEWAL TR FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S043
Product code
NKE
Decision date
2007-04-13
Classification
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement
TWO NEW SUPPLIERS OF RESISTORS USED IN THE CONTAK RENEWAL TR FAMILY OF DEVICES.
Summary
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Current openFDA PMA Record#

Device
CONTAK RENEWAL TR FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S043
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date
2007-04-13
Decision code
OK30
Date received
2007-03-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
TWO NEW SUPPLIERS OF RESISTORS USED IN THE CONTAK RENEWAL TR FAMILY OF DEVICES.