PMA P110008S007
- Device
- COFLEX INTERLAMINAR TECHNOLOGY
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S007
- Product code
- NQO
- Decision date
- 2017-03-10
- Classification
- Prosthesis, Spinous Process Spacer/plate
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval of changes to the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- COFLEX INTERLAMINAR TECHNOLOGY
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S007
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2017-03-10
- Decision code
- APPR
- Date received
- 2016-10-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of changes to the protocol for the post-approval study (PAS) protocol.