VITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWA
FDA premarket approval P990001/S017 · decided 2005-03-16
Approval details
- PMA number
- P990001
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWA
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2005-02-18
- Decision date
- 2005-03-16
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE VITATRON C60 DR (MODEL C60A3) AND VITATRON C20 SR (MODEL C20A3) IMPLANTABLE PULSE GENERATORS AND THEIR ASSOCIATED SOFTWARE (VSF11/VSF12 VERSION 1.0); AND THE T-SERIES APPLICATION SOFTWARE (VSF07/VSF08 VERSION 1.2); AND CD-ROM (VSE03/VSE04 VERSION 2.3).
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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