PMA P010015S487

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: S487
Product code: LWP
Decision date: 2021-12-09
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Implement a new electrostatic discharge handling tray used in manufacturing at Medtronic's internal supplier - Medtronic Tempe Campus.

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: S487
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2021-12-09
Decision code: OK30
Date received: 2021-11-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a new electrostatic discharge handling tray used in manufacturing at Medtronic's internal supplier - Medtronic Tempe Campus.