PMA P010031S777

Device: Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S777
Product code: NIK
Decision date: 2022-04-01
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Add the Cobalt and Chrome products in the Medtronic Polaris family to the repack process at the Americas Repack Center at the Distribution Center in Memphis, TN.

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: S777
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2022-04-01
Decision code: OK30
Date received: 2022-03-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add the Cobalt and Chrome products in the Medtronic Polaris family to the repack process at the Americas Repack Center at the Distribution Center in Memphis, TN.