PMA P140019S003
- Device
- i-FACTOR Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S003
- Product code
- NOX
- Decision date
- 2019-10-11
- Classification
- Filler, Bone Void, Synthetic Peptide
- Generic name
- Filler, bone void, synthetic peptide
- Approval order statement
- Approval for an updated package insert that incorporates the 24-month follow-up data from all subjects enrolled in the original clinical study.
Current openFDA PMA Record#
- Device
- i-FACTOR Peptide Enhanced Bone Graft
- Applicant
- Cerapedics, LLC
- PMA number
- P140019
- Supplement
- S003
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2019-10-11
- Decision code
- APPR
- Date received
- 2019-04-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for an updated package insert that incorporates the 24-month follow-up data from all subjects enrolled in the original clinical study.