PMA P140004S014
- Device
- Superion Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- Product code
- NQO
- Decision date
- 2019-09-10
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for the revised post-approval study protocol.
Current openFDA PMA Record#
- Device
- Superion Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S014
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2019-09-10
- Decision code
- APPR
- Date received
- 2018-04-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the revised post-approval study protocol.