MEDTRONIC VISION SOFTWARE (MODEL 9953A)
FDA premarket approval P980035/S003 · decided 1999-06-11
Approval details
- PMA number
- P980035
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC VISION SOFTWARE (MODEL 9953A)
- Applicant
- Medtronic, Inc.
- Date received
- 1999-05-19
- Decision date
- 1999-06-11
- Days to decision
- 23 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a modification to the Medtronic.Vision Model 9953A Series 1.3 Software, used with the Model 9790 Programmer, to correct a software installation anomaly.
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