PMA P010031

Device: Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S813
Product code: NIK
Decision date: 2026-09-25
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: updates to visual inspection criteria for anode components at the Medtronic Energy and Component Center (MECC)

Current openFDA PMA Record#

Device: Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S932
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-09-25
Decision code: OK30
Date received: 2026-08-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to visual inspection criteria for anode components at the Medtronic Energy and Component Center (MECC)