- Device
- Vercise Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S090
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement the utilization of an alternate Laser Excise System for the Printed Circuit Board Assemblies used in the Wavewriter Alpha and Vercise Genus Rechargeable Implantable Pulse Generators