VNS THERAPY SYSTEM
FDA premarket approval P970003/S149 · decided 2012-06-20
Approval details
- PMA number
- P970003
- Supplement
- S149
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VNS THERAPY SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2012-06-06
- Decision date
- 2012-06-20
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- NEW ROUTING FIXTURE IN THE MANUFACTURE OF THE PULSE GENERATOR PRINTED CIRCUIT BOARD ASSEMBLY.
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