PMA P110008S013
- Device
- coflex Interlaminar Stabilization Device
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S013
- Product code
- NQO
- Decision date
- 2021-03-31
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- coflex Interlaminar Stabilization Device
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S013
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2021-03-31
- Decision code
- APPR
- Date received
- 2021-01-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.