PMA P010015S576

Device: Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S576
Product code: LWP
Decision date: 2026-01-23
Classification: Cardiovascular
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: modification to the cleaning process of manufacturing components received at the Medtronic final device manufacturing site

Current openFDA PMA Record#

Device: Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S576
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2026-01-23
Decision code: OK30
Date received: 2026-01-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modification to the cleaning process of manufacturing components received at the Medtronic final device manufacturing site