PMA P110008S012
- Device
- coflex® Interlaminar Technology
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S012
- Product code
- NQO
- Decision date
- 2020-08-05
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for additional warnings in the labeling.
Current openFDA PMA Record#
- Device
- coflex® Interlaminar Technology
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S012
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2020-08-05
- Decision code
- APPR
- Date received
- 2020-07-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for additional warnings in the labeling.