PMA P150031S032
- Device
- Deep Brain Stimulation (DBS) Systems (Vercise, Vercise PC, and Vercise Gevia)
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S032
- Product code
- NHL
- Decision date
- 2020-05-13
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Approval order statement
- Update to the inspection frequency for the O.R. Cables.
Current openFDA PMA Record#
- Device
- Deep Brain Stimulation (DBS) Systems (Vercise, Vercise PC, and Vercise Gevia)
- Applicant
- Boston Scientific Corp
- PMA number
- P150031
- Supplement
- S032
- Product code
- NHL
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Decision date
- 2020-05-13
- Decision code
- OK30
- Date received
- 2020-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the inspection frequency for the O.R. Cables.