PMA P030005

Device
CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S227
Product code
NKE
Decision date
2026-04-01
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

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
S252
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date
2026-04-01
Decision code
OK30
Date received
2026-03-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier