i-FACTOR Peptide Enhanced Bone Graft
FDA premarket approval P140019/S006 · decided 2022-02-16
Approval details
- PMA number
- P140019
- Supplement
- S006
- Supplement type
- 30-Day Notice
- 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
- 2022-01-19
- Decision date
- 2022-02-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- Statement
- Modification to the endotoxin test plan.
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