VIRTUOSO ICD
FDA premarket approval P980016/S076 · decided 2006-07-12
Approval details
- PMA number
- P980016
- Supplement
- S076
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIRTUOSO ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-06-19
- Decision date
- 2006-07-12
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR ADDING SUPPORT FOR THE CONCERTO MODEL C154DWK AND VIRTUOSO MODELS D154AWG/D154VWC TO THE MODEL 2020A CARDIOSIGHT READERS AND THE CORRECTION OF AN ANOMALY IN THE MODEL 2491 DDMA AFFECTING THE ENTRUST FAMILY OF ICDS.
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