PMA P140019S004
- Device
- i-FACTOR Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S004
- Product code
- NOX
- Decision date
- 2020-07-22
- Generic name
- Filler, bone void, synthetic peptide
- Approval order statement
- Approval for updated labeling to include the results from the completed 72-month follow-up post-approval study.
Current openFDA PMA Record#
- Device
- i-FACTOR Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S004
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2020-07-22
- Decision code
- APPR
- Date received
- 2020-06-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to include the results from the completed 72-month follow-up post-approval study.