Evera MRI, Evera, Marquis, Secura Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, Visia AF
FDA premarket approval P980016/S702 · decided 2019-06-11
Approval details
- PMA number
- P980016
- Supplement
- S702
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Evera MRI, Evera, Marquis, Secura Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, Visia AF
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-03-25
- Decision date
- 2019-06-11
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to firmware version 7.4 for Model 24950 MyCareLink monitors.
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