- Device
- Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S030
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2020-04-24
- Decision code
- OK30
- Date received
- 2020-03-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an additional ethylene oxide (EO) sterilization chamber and associated sterilization process located at Boston Scientific Dorado Manufacturing site (BSC-DOR).