PMA P030005S206

Device: VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S206
Product code: NKE
Decision date: 2020-12-11
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: Move the Incoming Quality Assurance Acceptance Activity for testing levels of elements in Lithium Hydroxide from an external laboratory to the material supplier.

Current openFDA PMA Record#

Device: VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P
Applicant: Guidant Corp.
PMA number: P030005
Supplement: S206
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2020-12-11
Decision code: OK30
Date received: 2020-12-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Move the Incoming Quality Assurance Acceptance Activity for testing levels of elements in Lithium Hydroxide from an external laboratory to the material supplier.