PMA P010015

Device: Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S513
Product code: LWP
Decision date: 2026-05-14
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for updates to the protection diode component and associated manufacturing changes for cardiac resynchronization therapy pacemakers (CRT-Ps) and implantable pulse generators (IPGs).

Current openFDA PMA Record#

Device: Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S583
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-05-14
Decision code: APPR
Date received: 2026-02-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to the protection diode component and associated manufacturing changes for cardiac resynchronization therapy pacemakers (CRT-Ps) and implantable pulse generators (IPGs).