PMA P150031S078
- Device
- Vercise Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S078
- Product code
- NHL
- Decision date
- 2024-11-07
- Classification
- Neurology
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Approval order statement
- qualification of a new, controlled environment area at the manufacturing facility in Clonmel, Ireland
Current openFDA PMA Record#
- Device
- Vercise Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S078
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2024-11-07
- Decision code
- OK30
- Date received
- 2024-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of a new, controlled environment area at the manufacturing facility in Clonmel, Ireland