PMA P010015S450

Device: Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S450
Product code: LWP
Decision date: 2020-09-30
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Implementation of modifications of selected manufacturing processes related to the packaging processes associated with the Backfill Hole Weld Process.

Current openFDA PMA Record#

Device: Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S450
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2020-09-30
Decision code: OK30
Date received: 2020-09-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of modifications of selected manufacturing processes related to the packaging processes associated with the Backfill Hole Weld Process.