PMA P140004S007
- Device
- SUPERION INTERSPINOUS SPACER
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S007
- Product code
- NQO
- Decision date
- 2017-02-21
- Classification
- Prosthesis, Spinous Process Spacer/plate
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval of minor modifications to the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- SUPERION INTERSPINOUS SPACER
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S007
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2017-02-21
- Decision code
- APPR
- Date received
- 2017-01-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of minor modifications to the protocol for the post-approval study (PAS) protocol.