I-FACTOR PEPTIDE ENHANCED BONE GRAFT
FDA premarket approval P140019/S002 · decided 2016-03-18
Approval details
- PMA number
- P140019
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- I-FACTOR PEPTIDE ENHANCED BONE GRAFT
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Cerapedics, LLC
- Date received
- 2016-01-19
- Decision date
- 2016-03-18
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- Statement
- Approval for the inclusion of additional graft sizes, i.e., 1.0 and 2.5cc, to the approved 5.0cc graft.
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