Primo MRITM SureScan TM & Mirro MRITM SureScan TM
FDA premarket approval P980016/S653 · decided 2018-03-01
Approval details
- PMA number
- P980016
- Supplement
- S653
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Primo MRITM SureScan TM & Mirro MRITM SureScan TM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-12-04
- Decision date
- 2018-03-01
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the addition of the Primo MRI SureScan and Mirro MRI SureScan ICDs to the Evera MRI Conditional family of devices.
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