PRODISC-L TOTAL DISC REPLACEMENT
FDA premarket approval P050010/S012 · decided 2012-07-10
Approval details
- PMA number
- P050010
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRODISC-L TOTAL DISC REPLACEMENT
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Centinel Spine, LLC
- Date received
- 2011-04-26
- Decision date
- 2012-07-10
- Days to decision
- 441 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- APPROVAL OF A PROTOCOL FOR EXTENSION OF SHELF-LIFE FOR THE POLYETHYLENE INLAY COMPONENT FROM THREE (3) YEARS TO FIVE (5) YEARS.
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