Vercise PC DBS System / Vercise Gevia DBS System
FDA premarket approval P150031/S001 · decided 2019-01-10
Approval details
- PMA number
- P150031
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Vercise PC DBS System / Vercise Gevia DBS System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2017-12-21
- Decision date
- 2019-01-10
- Days to decision
- 385 days
- Decision code
- APPR
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the Vercise PC Deep Brain Stimulation (DBS) System and Vercise Gevia Deep Brain Stimulation (DBS) System.
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