Vercise, Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems
FDA premarket approval P150031/S039 · decided 2021-11-15
Approval details
- PMA number
- P150031
- Supplement
- S039
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Vercise, Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2021-01-29
- Decision date
- 2021-11-15
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- NHL
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval to add alternate suppliers for the patient contacting components of the SureTek Burr Hole Cover Kits, used during the deep brain stimulation (DBS) process, for the Vercise, Vercise PC, Vercise Gevia, and Vercise Genus DBS Systems
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