i-FACTOR® Peptide Enhanced Bone Graft
FDA premarket approval P140019/S007 · decided 2022-11-15
Approval details
- PMA number
- P140019
- Supplement
- S007
- 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
- 2022-10-19
- Decision date
- 2022-11-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Westminster, CO
- Statement
- Change to the manufacturing process for i-FACTOR® Bone Graft to allow blending of up to four batches of P-15 coated anorganic bone mineral (ABM).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.