FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Filler, Bone Void, Synthetic Peptide
PMA: P100006
·
Supplement: S012
·
Decision Nov 17, 2021
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Filler, Bone Void, Synthetic Peptide
- Trade Name
- AUGMENT Bone Graft and AUGMENT Injectable
- PMA Number
- P100006
- Supplement Number
- S012
- 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
- November 17, 2021
- Date Received
- September 9, 2021
- Supplement Type
- Real-Time Process
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for use of an alternate cold chain shipping unit, the AeroSafe A50 13L shipper, in addition to the current U39 shipper utilized for AUGMENT Bone Graft and AUGMENT Injectable.
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 |