PMA P140019S007
- Device
- i-FACTOR® Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S007
- Product code
- NOX
- Decision date
- 2022-11-15
- Generic name
- Filler, bone void, synthetic peptide
- Approval order 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).
Current openFDA PMA Record#
- Device
- i-FACTOR® Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S007
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2022-11-15
- Decision code
- OK30
- Date received
- 2022-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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).