Vercise S8 Adapter
FDA premarket approval P150031/S055 · decided 2023-09-06
Approval details
- PMA number
- P150031
- Supplement
- S055
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Vercise S8 Adapter
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2023-03-17
- Decision date
- 2023-09-06
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the Vercise Adapter S8 and the addition of the use with Abbott Lead models (6170, 6171, 6172, 6173, 6178, 6179, 6180, and 6181) to the Vercise Neural Navigator 5 (VNN5) software.
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