PMA P070001S001
- Device
- PRODISC-C TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S001
- Product code
- MJO
- Decision date
- 2008-04-30
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR EXTENSION OF SHELF LIFE TO TWO (2) YEARS.
Current openFDA PMA Record#
- Device
- PRODISC-C TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S001
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2008-04-30
- Decision code
- APPR
- Date received
- 2008-01-31
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR EXTENSION OF SHELF LIFE TO TWO (2) YEARS.