FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Filler, Bone Void, Synthetic Peptide
PMA: P140019
·
Supplement: S004
·
Decision Jul 22, 2020
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Filler, Bone Void, Synthetic Peptide
- Trade Name
- i-FACTOR Peptide Enhanced Bone Graft
- PMA Number
- P140019
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- NOX
- Generic Name
- Filler, bone void, synthetic peptide
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 22, 2020
- Date Received
- June 15, 2020
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
Approval for updated labeling to include the results from the completed 72-month follow-up post-approval study.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NOX | Filler, Bone Void, Synthetic Peptide | FDA class 3 | Unknown |