Primo MRI DR/VR SureScan; Mirro MRI DR/VR SureScan
FDA premarket approval P980016/S659 · decided 2018-03-27
Approval details
- PMA number
- P980016
- Supplement
- S659
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Primo MRI DR/VR SureScan; Mirro MRI DR/VR SureScan
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-03-08
- Decision date
- 2018-03-27
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Implementation of previously accepted changes to align manufacturing of Primo MRI and Mirro MRI ICDs with existing manufacturing processes.
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