- Device
- Vercise, Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S039
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2021-11-15
- Decision code
- APPR
- Date received
- 2021-01-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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