PRODISC-L
FDA premarket approval P050010/S013 · decided 2014-07-31
Approval details
- PMA number
- P050010
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- PRODISC-L
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2012-11-08
- Decision date
- 2014-07-31
- Days to decision
- 630 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- APPROVAL FOR MODIFIED LABELING TO REFLECT FINDINGS OF THE POST-APPROVAL STUDY (PAS).
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510(k) clearances by this applicant
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| prodisc® L Instruments (K250554) | Centinel Spine, LLC | 2025-04-25 |
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