PMA P140004S010
- Device
- Superion® Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S010
- Product code
- NQO
- Decision date
- 2018-11-16
- Classification
- Prosthesis, Spinous Process Spacer/plate
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for revised labeling which incorporates data from the completed Post-Approval Study.
Current openFDA PMA Record#
- Device
- Superion® Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S010
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2018-11-16
- Decision code
- APPR
- Date received
- 2017-11-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for revised labeling which incorporates data from the completed Post-Approval Study.