PMA P010031S760

Device: Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P010031
Supplement: S760
Product code: NIK
Decision date: 2021-11-03
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Implement improvements for the Final Functional Test for hybrids.

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: S760
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2021-11-03
Decision code: OK30
Date received: 2021-10-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement improvements for the Final Functional Test for hybrids.