MEDTRONIC VISION SOFTWARE SERIES 4.0
FDA premarket approval P980016/S017 · decided 2001-03-15
Approval details
- PMA number
- P980016
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC VISION SOFTWARE SERIES 4.0
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-02-22
- Decision date
- 2001-03-15
- Days to decision
- 21 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE PROGRAMMING SOFTWARE TO BE USED WITH THE MEDTRONIC GEM DR (MODEL 9960 SOFTWARE), GEMII VR (MODEL 9965 SOFTWARE), AND GEM II DR (MODEL 9964 SOFTWARE) ICD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OF MEDTRONIC VISION SOFTWARE SERIES 4.0.
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