PMA P150031S047
- Device
- Vercise Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S047
- Product code
- NHL
- Decision date
- 2021-12-14
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Approval order statement
- Use of a new controlled environment area at the Boston Scientific Corporation Dorado Puerto Rico facility.
Current openFDA PMA Record#
- Device
- Vercise Deep Brain Stimulation (DBS) Systems
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S047
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2021-12-14
- Decision code
- OK30
- Date received
- 2021-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a new controlled environment area at the Boston Scientific Corporation Dorado Puerto Rico facility.