- Device
- Vercise Genus™ Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S077
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2024-09-04
- Decision code
- OK30
- Date received
- 2024-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- add an optional dry heat oven bake step for the Placement Removal Tool, a non-patient contacting component of the SureTek Burr Hole Cover kit