PMA P030005S203

Device: PG VALITUDE CRT-P and PG VISIONIST CRT-P
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S203
Product code: NKE
Decision date: 2020-10-22
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: Change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves.

Current openFDA PMA Record#

Device: PG VALITUDE CRT-P and PG VISIONIST CRT-P
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S203
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2020-10-22
Decision code: OK30
Date received: 2020-10-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves.