PMA P150031S081
- Device
- Vercise Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S081
- Product code
- NHL
- Decision date
- 2025-01-08
- Classification
- Neurology
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Approval order statement
- to add an alternate laser welding system at your firm's manufacturing facility in Dorado, Puerto Rico
Current openFDA PMA Record#
- Device
- Vercise Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S081
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2025-01-08
- Decision code
- OK30
- Date received
- 2024-12-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an alternate laser welding system at your firm's manufacturing facility in Dorado, Puerto Rico