FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Filler, Bone Void, Non-Osteoinduction
PMA: P900039
·
Supplement: S009
·
Decision Feb 1, 1996
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Filler, Bone Void, Non-Osteoinduction
- Trade Name
- COLLAGRAFT BONE GRAFT MATRIX
- PMA Number
- P900039
- Supplement Number
- S009
- Device Class
- FDA Class 3
- Product Code
- MBS
- Generic Name
- Filler, bone void, non-osteoinduction
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 1, 1996
- Date Received
- October 10, 1995
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING CHANGE
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 |
|---|---|---|---|
| MBS | Filler, Bone Void, Non-Osteoinduction | FDA class 3 | Unknown |