VITRTUOSO MODELS D154AWG/D154VWC
FDA premarket approval P980016/S095 · decided 2007-03-26
Approval details
- PMA number
- P980016
- Supplement
- S095
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITRTUOSO MODELS D154AWG/D154VWC
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-02-12
- Decision date
- 2007-03-26
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE 9-PIN FILTERED FEEDTHROUGH (FFT) OF THE MEDTRONIC CONCERTO MODEL C154DWK AND VIRTUOSO MODELS D154AWG/D154VWC DEVICES.
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