PMA P010015

Device: Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S513
Product code: LWP
Decision date: 2026-07-16
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: approval of new burn-in equipment and process for electrical testing of capacitors

Current openFDA PMA Record#

Device: Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S587
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-07-16
Decision code: OK30
Date received: 2026-06-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of new burn-in equipment and process for electrical testing of capacitors