VIRTUOSO DR,VIRTUOSO VR,SECURA DR,MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR,PROTE
FDA premarket approval P980016/S431 · decided 2013-10-07
Approval details
- PMA number
- P980016
- Supplement
- S431
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIRTUOSO DR,VIRTUOSO VR,SECURA DR,MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR,PROTE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-08-06
- Decision date
- 2013-10-07
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A FIRMWARE UPDATE TO THE MODEL 2490C CARELINK REMOTE HOME MONITOR FOR THE DEVICES.
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