FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Filler, Bone Void, Synthetic Peptide
PMA: P100006
·
Supplement: S003
·
Decision Oct 6, 2016
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Filler, Bone Void, Synthetic Peptide
- Trade Name
- AUGMENT BONE GRAFT
- PMA Number
- P100006
- Supplement Number
- S003
- 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
- October 6, 2016
- Date Received
- September 30, 2015
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol - OSB
- Expedited Review
- N
Advisory Committee Statement
Approval for termination of the New Enrollment Postapproval 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 |