- Device
- Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S713
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-04-23
- Decision code
- APPR
- Date received
- 2019-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Cobalt XT, Cobalt, and Crome MRI SureScan Implantable Cardioverter Defibrillator (ICD) and ICD with Cardiac Resynchronization (CRT-D) Systems.