- Device
- Vercise Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S079
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2024-12-18
- Decision code
- OK30
- Date received
- 2024-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an alternative Macro Laser Weld system to the existing Laser Weld system for the creation of a weld seam around the case half seam and feedthru and case of WaveWriter Alpha and Vercise Genus Implantable Pulse Generator (IPG} devices at the Boston Scientific Corp. Clonmel manufacturing site