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: 2026-10-05
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: process and equipment updates of the manufacturing process of MR Delta 26H3 batteries used in Medtronic CRM devices

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: S590
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-10-05
Decision code: OK30
Date received: 2026-09-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: process and equipment updates of the manufacturing process of MR Delta 26H3 batteries used in Medtronic CRM devices