MODEL 201 PROGRAMMING WAND
FDA premarket approval P970003/S167 · decided 2014-01-02
Approval details
- PMA number
- P970003
- Supplement
- S167
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MODEL 201 PROGRAMMING WAND
- Generic name
- Stimulator, autonomic nerve, implanted (depression)
- Applicant
- LivaNova USA, Inc.
- Date received
- 2013-12-03
- Decision date
- 2014-01-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MUZ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- REPLACE THE CAPACITOR USED IN THE ASSEMBLY OF THE PRINTED CIRCUIT BOARDS FOR THE PROGRAMMING WAND.
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