PMA P010015S495

Device: Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S495
Product code: LWP
Decision date: 2022-04-21
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: Updates to the equipment used for monitoring temperature and humidity in Controlled Environment Area number 2 at Medtronic Rice Creek.

Current openFDA PMA Record#

Device: Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena
Applicant: Medtronic, Inc.
PMA number: P010015
Supplement: S495
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2022-04-21
Decision code: OK30
Date received: 2022-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Updates to the equipment used for monitoring temperature and humidity in Controlled Environment Area number 2 at Medtronic Rice Creek.