PMA P010015S581

Device: Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S581
Product code: LWP
Decision date: 2026-04-30
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Approval for updates to the manufacturing acceptance conditions for plated through holes in hybrid subassemblies incorporated into implantable cardiac rhythm management devices.

Current openFDA PMA Record#

Device: Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S581
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-04-30
Decision code: APPR
Date received: 2026-01-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to the manufacturing acceptance conditions for plated through holes in hybrid subassemblies incorporated into implantable cardiac rhythm management devices.