PMA P010031

Device: Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S813
Product code: NIK
Decision date: 2026-07-16
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: approval of new burn-in equipment and process for electrical testing of capacitors

Current openFDA PMA Record#

Device: Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S926
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-07-16
Decision code: OK30
Date received: 2026-06-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of new burn-in equipment and process for electrical testing of capacitors