VIRTUOSO II DR/VR ICD & VARIOUS FAMILIES OF MAXIMO II, PROTECTA & SECURA ICDS
FDA premarket approval P980016/S364 · decided 2012-07-25
Approval details
- PMA number
- P980016
- Supplement
- S364
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIRTUOSO II DR/VR ICD & VARIOUS FAMILIES OF MAXIMO II, PROTECTA & SECURA ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-06-29
- Decision date
- 2012-07-25
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE L409 INTEGRATED CIRCUIT.
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