VITATRON BRILLIANT S+ VDD LEAD
FDA premarket approval P890003/S318 · decided 2014-09-30
Approval details
- PMA number
- P890003
- Supplement
- S318
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITATRON BRILLIANT S+ VDD LEAD
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2014-08-15
- Decision date
- 2014-09-30
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR USE OF NEW SILICONE INSULATION TUBING MATERIALS.
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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