PMA P030005S218

Device: PG VALITUDE CRT-P, PG VISIONIST CRT-P
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S218
Product code: NKE
Decision date: 2022-07-13
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: Addition of Ansell nitrile gloves as an alternative glove for use during cardiac rhythm management (CRM) pulse generator manufacturing at the St. Paul site.

Current openFDA PMA Record#

Device: PG VALITUDE CRT-P, PG VISIONIST CRT-P
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S218
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2022-07-13
Decision code: OK30
Date received: 2022-06-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of Ansell nitrile gloves as an alternative glove for use during cardiac rhythm management (CRM) pulse generator manufacturing at the St. Paul site.