PMA P030005S194

Device: PG VALITUDE CRT-P IS1 EL, IS4 EL, PG VISIONIST CRT-P IS1 EL, LV1 EL, IS4 EL
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S194
Product code: NKE
Decision date: 2020-01-28
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: Reduce the burn-in process temperature setting used during manufacturing of the Integrated Circuit modules of the NG3/NG4 and Accolade Pulse Generator product families.

Current openFDA PMA Record#

Device: PG VALITUDE CRT-P IS1 EL, IS4 EL, PG VISIONIST CRT-P IS1 EL, LV1 EL, IS4 EL
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S194
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2020-01-28
Decision code: OK30
Date received: 2020-01-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduce the burn-in process temperature setting used during manufacturing of the Integrated Circuit modules of the NG3/NG4 and Accolade Pulse Generator product families.