PMA P110008S010
- Device
- COFLEX® INTERLAMINAR TECHNOLOGY
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S010
- Product code
- NQO
- Decision date
- 2018-04-20
- Classification
- Prosthesis, Spinous Process Spacer/plate
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for a manufacturing site located at Diener Implants GmbH, Rudolf-Diesel-Strasse: 18, Tuttllingen, Germany.
Current openFDA PMA Record#
- Device
- COFLEX® INTERLAMINAR TECHNOLOGY
- Applicant
- Companion Spine France
- PMA number
- P110008
- Supplement
- S010
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2018-04-20
- Decision code
- APPR
- Date received
- 2017-08-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Diener Implants GmbH, Rudolf-Diesel-Strasse: 18, Tuttllingen, Germany.