MEDTRONIC VISION SOFTWARE SERIES 4.0
FDA premarket approval P900061/S043 · decided 2001-03-15
Approval details
- PMA number
- P900061
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC VISION SOFTWARE SERIES 4.0
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2001-02-22
- Decision date
- 2001-03-15
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE PROGRAMMING SOFTWARE TO BE USED WITH THE MEDTRONIC GEM (MODEL 9962 SOFTWARE) ICD SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OF MEDTRONIC VISION SOFTWARE SERIES 4.0.
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