VITATRON C60 DR MODEL C60A3, VITATRON C20 SR MODEL C20A3, VITATRON T60 DR MODEL T60A1, AND VITATRON T20 SR MODEL T20A1
FDA premarket approval P990001/S024 · decided 2006-03-31
Approval details
- PMA number
- P990001
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITATRON C60 DR MODEL C60A3, VITATRON C20 SR MODEL C20A3, VITATRON T60 DR MODEL T60A1, AND VITATRON T20 SR MODEL T20A1
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2006-01-19
- Decision date
- 2006-03-31
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE REVISIONS.
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