PMA P070001S016
- Device
- ProDisc-C Total Disc Replacement
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S016
- Product code
- MJO
- Decision date
- 2017-10-20
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Change to the sealing parameters for the sterile packaging process.
Current openFDA PMA Record#
- Device
- ProDisc-C Total Disc Replacement
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S016
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2017-10-20
- Decision code
- OK30
- Date received
- 2017-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the sealing parameters for the sterile packaging process.