PMA P140004S001
- Device
- SUPERION INTERSPINOUS SPACER
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S001
- Product code
- NQO
- Decision date
- 2015-11-18
- Classification
- Prosthesis, Spinous Process Spacer/plate
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- APPROVAL OF POST-APPROVAL STUDY 1 FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- SUPERION INTERSPINOUS SPACER
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S001
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2015-11-18
- Decision code
- APPR
- Date received
- 2015-06-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF POST-APPROVAL STUDY 1 FOR THE DEVICE.