Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, VIsia AF, Primo DR and VR M
FDA premarket approval P980016/S685 · decided 2018-10-18
Approval details
- PMA number
- P980016
- Supplement
- S685
- 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, Primo DR and VR M
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2018-08-22
- Decision date
- 2018-10-18
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the remote monitoring systems for Attesta and Sphera MRI SureScan IPG devices.
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