PMA P110008S009
- Device
- Paradigm Spine Coflex Interlaminar Stabilization Device
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S009
- Product code
- NQO
- Decision date
- 2018-06-21
- Classification
- Prosthesis, Spinous Process Spacer/plate
- 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
- Paradigm Spine Coflex Interlaminar Stabilization Device
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S009
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2018-06-21
- Decision code
- APPR
- Date received
- 2017-07-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.