PMA P050010S008
- Device
- PRODISC -L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S008
- Product code
- MJO
- Decision date
- 2011-02-16
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR MR CONDITIONAL LABELING.
Current openFDA PMA Record#
- Device
- PRODISC -L TOTAL DISC REPLACEMENT
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S008
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2011-02-16
- Decision code
- APPR
- Date received
- 2010-08-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MR CONDITIONAL LABELING.