Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT,
FDA premarket approval P980016/S613 · decided 2017-02-17
Approval details
- PMA number
- P980016
- Supplement
- S613
- 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,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-11-23
- Decision date
- 2017-02-17
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for firmware changes (version M8.0) to the MyCareLink Patient Monitor Model 24950.
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