PMA P070001S002
- Device
- PRODISC C TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S002
- Product code
- MJO
- Decision date
- 2008-08-11
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- PRODISC C TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S002
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2008-08-11
- Decision code
- APPR
- Date received
- 2008-03-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY.