PMA P140004S004
- Device
- Superion® Interspinous Spacer
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S004
- Product code
- NQO
- Decision date
- 2016-10-11
- Classification
- Prosthesis, Spinous Process Spacer/plate
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for a design modification to the Superion® implants and new labeling.
Current openFDA PMA Record#
- Device
- Superion® Interspinous Spacer
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S004
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2016-10-11
- Decision code
- APPR
- Date received
- 2016-07-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design modification to the Superion® implants and new labeling.