i-FACTOR Peptide Enhanced Bone Graft
FDA premarket approval P140019/S003 · decided 2019-10-11
Approval details
- PMA number
- P140019
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- i-FACTOR Peptide Enhanced Bone Graft
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Cerapedics, LLC
- Date received
- 2019-04-17
- Decision date
- 2019-10-11
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- Statement
- Approval for an updated package insert that incorporates the 24-month follow-up data from all subjects enrolled in the original clinical study.
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