PMA P030005S165

Device
Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S165
Product code
NKE
Decision date
2018-01-07
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 multiple software upgrades and updates for the Model 3300 Latitude Programming System.
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
S165
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date
2018-01-07
Decision code
APPR
Date received
2017-10-20
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for multiple software upgrades and updates for the Model 3300 Latitude Programming System.