VITATRON T-SERIES SOFTWARE MODEL VSF07/08, VSE03/04
FDA premarket approval P990001/S019 · decided 2005-09-21
Approval details
- PMA number
- P990001
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITATRON T-SERIES SOFTWARE MODEL VSF07/08, VSE03/04
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2005-05-18
- Decision date
- 2005-09-21
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CHANGES TO THE CALIBRATOR AND CONTROL RECOVERY RANGES.
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