Sprint Quattro Secure S MRI SureScan Lead & Sprint Quattro Secure MRI SureScan Lead
FDA premarket approval P920015/S204 · decided 2018-03-01
Approval details
- PMA number
- P920015
- Supplement
- S204
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Sprint Quattro Secure S MRI SureScan Lead & Sprint Quattro Secure MRI SureScan Lead
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2017-12-04
- Decision date
- 2018-03-01
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NVY
- 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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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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