INFUSE BONE GRAFT
FDA premarket approval P000054/S010 · decided 2007-07-03
Approval details
- PMA number
- P000054
- Supplement
- S010
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INFUSE BONE GRAFT
- Generic name
- Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Date received
- 2006-12-22
- Decision date
- 2007-07-03
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- MPW
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FORA NEW TEST METHOD FOR THE QUANTITATIVE ANALYSIS OF POLYSORBATE-80 EXCIPIENT FOR THE RELEASE OF RHBMP-2.
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