PMA P030005S133

Device
CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S133
Product code
NKE
Decision date
2016-05-03
Classification
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement
Approval for an alternate capacitor to be used in the communications module.
Summary
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Current openFDA PMA Record#

Device
CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S133
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date
2016-05-03
Decision code
APPR
Date received
2016-02-17
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for an alternate capacitor to be used in the communications module.