VIRTUOSO,SECURA, MAXIMO II ,VIRTUOSO II , PROTECTA XT ,PROTECTA VT,EVERA (XT/S) ,EVERA S AND XT VR AND DR'S
FDA premarket approval P980016/S535 · decided 2015-05-04
Approval details
- PMA number
- P980016
- Supplement
- S535
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIRTUOSO,SECURA, MAXIMO II ,VIRTUOSO II , PROTECTA XT ,PROTECTA VT,EVERA (XT/S) ,EVERA S AND XT VR AND DR'S
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-03-06
- Decision date
- 2015-05-04
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MEDTRONIC MODEL 25000 MYCARELINK SMART READER FOR USE WITH THE DEVICES.
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