PMA P050010S013
- Device
- PRODISC-L
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S013
- Product code
- MJO
- Decision date
- 2014-07-31
- Classification
- Prosthesis, Intervertebral Disc
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- APPROVAL FOR MODIFIED LABELING TO REFLECT FINDINGS OF THE POST-APPROVAL STUDY (PAS).
Current openFDA PMA Record#
- Device
- PRODISC-L
- Applicant
- Centinel Spine, LLC
- PMA number
- P050010
- Supplement
- S013
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2014-07-31
- Decision code
- APPR
- Date received
- 2012-11-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR MODIFIED LABELING TO REFLECT FINDINGS OF THE POST-APPROVAL STUDY (PAS).