Evera S, Evera XT, Maximo II, Protecta, Protecta XT, Secura, Virtuoso II, Cobalt, Cobalt XT, Crome, Crome XT
FDA premarket approval P980016/S842 · decided 2023-02-08
Approval details
- PMA number
- P980016
- Supplement
- S842
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Evera S, Evera XT, Maximo II, Protecta, Protecta XT, Secura, Virtuoso II, Cobalt, Cobalt XT, Crome, Crome XT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2022-11-17
- Decision date
- 2023-02-08
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the Alert Management Feature/System for the CareLink network.
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