PMA P070001S017
- Device
- prodisc C Total Disc Replacement
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S017
- Product code
- MJO
- Decision date
- 2019-05-31
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for updated labeling to reflect the Post Approval Study Protocol.
Current openFDA PMA Record#
- Device
- prodisc C Total Disc Replacement
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S017
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2019-05-31
- Decision code
- APPR
- Date received
- 2018-12-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updated labeling to reflect the Post Approval Study Protocol.