PMA P150031S082
- Device
- Deep Brain Stimulation (DBS)
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S082
- Product code
- NHL
- Decision date
- 2025-03-17
- Classification
- Neurology
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Approval order statement
- RTR supplement, which requested minor label and package updates for SCS and DBS systems.
Current openFDA PMA Record#
- Device
- Deep Brain Stimulation (DBS)
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S082
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2025-03-17
- Decision code
- APPR
- Date received
- 2025-01-16
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- RTR supplement, which requested minor label and package updates for SCS and DBS systems.