Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD
FDA premarket approval P980016/S713 · decided 2020-04-23
Approval details
- PMA number
- P980016
- Supplement
- S713
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-07-01
- Decision date
- 2020-04-23
- Days to decision
- 297 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for Cobalt XT, Cobalt, and Crome MRI SureScan Implantable Cardioverter Defibrillator (ICD) and ICD with Cardiac Resynchronization (CRT-D) Systems.
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