- Device
- Vercise Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S067
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2023-12-29
- Decision code
- OK30
- Date received
- 2023-12-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a new ISO 14644:2015 Level 8 Controlled Environmental Area at your firm's Arden Hills, Minnesota facility