VNS THERAPY SYSTEM
FDA premarket approval P970003/S148 · decided 2012-07-23
Approval details
- PMA number
- P970003
- Supplement
- S148
- Supplement type
- Real-Time Process
- Trade name
- VNS THERAPY SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2012-05-24
- Decision date
- 2012-07-23
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE MODEL 250 PROGRAMMING SOFTWARE UPGRADE FROM VERSION 8.0 TO 8.1 AND THE ADDITION OF A NEW COMPACT FLASHCARD.
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