PMA P110008S006
- Device
- coflex® Interlaminar Technology
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S006
- Product code
- NQO
- Decision date
- 2016-11-30
- Classification
- Prosthesis, Spinous Process Spacer/plate
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for a change to the coflex® labeling to indicate a 5-year shelf-life for coflex® devices manufactured by the second source manufacturer, Orchid.
Current openFDA PMA Record#
- Device
- coflex® Interlaminar Technology
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S006
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2016-11-30
- Decision code
- APPR
- Date received
- 2016-09-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the coflex® labeling to indicate a 5-year shelf-life for coflex® devices manufactured by the second source manufacturer, Orchid.