FDA.reportPublic FDA data

PMA P030005S210

Device
VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S210
Product code
NKE
Decision date
2021-09-03
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement
Approval for the addition of Platinum/Iridium feedthru wires as an alternate to the Palladium/Iridium feedthru wires used in the Filtered Feedthru Assembly and minor design changes updating the extended life battery stack insulator.

Current openFDA PMA Record#

Device
VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4
Applicant
Guidant Corp.
PMA number
P030005
Supplement
S210
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date
2021-09-03
Decision code
APPR
Date received
2021-06-11
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the addition of Platinum/Iridium feedthru wires as an alternate to the Palladium/Iridium feedthru wires used in the Filtered Feedthru Assembly and minor design changes updating the extended life battery stack insulator.