PMA P010015S502

Device: Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S502
Product code: LWP
Decision date: 2022-07-19
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Reduce the frequency of the seamweld monitoring currently used to control the weld penetration at the welded interface between the left-hand and right-hand shields.

Current openFDA PMA Record#

Device: Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S502
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2022-07-19
Decision code: OK30
Date received: 2022-07-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduce the frequency of the seamweld monitoring currently used to control the weld penetration at the welded interface between the left-hand and right-hand shields.