VNS THERAPY MODEL 302 LEAD
FDA premarket approval P970003/S184 · decided 2015-08-28
Approval details
- PMA number
- P970003
- Supplement
- S184
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VNS THERAPY MODEL 302 LEAD
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2015-07-29
- Decision date
- 2015-08-28
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- REMOVAL OF AN ACETONE AND ISOPROPYL ALCOHOL PRE-CONDITIONING TREATMENT STEP IN THE MANUFACTURE OF YOUR MODEL 302 LEADS FOR THE VNS THERAPY SYSTEM.
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510(k) clearances by this applicant
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|---|---|---|
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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