VIRTUOSO DR/VR
FDA premarket approval P980016/S130 · decided 2008-07-18
Approval details
- PMA number
- P980016
- Supplement
- S130
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VIRTUOSO DR/VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-05-21
- Decision date
- 2008-07-18
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR USE OF AN ALTERNATE SHELF PACKAGE CONFIGURATION FOR MEDTRONIC¿S CONCERTO CRT-D AND VIRTUOSO ICD DEVICES.
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