FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Tissue Graft Of 6mm And Greater
PMA: P800058
·
Supplement: S011
·
Decision Sep 19, 1991
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Tissue Graft Of 6mm And Greater
- Trade Name
- N.C.G.T. GRAFT
- PMA Number
- P800058
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- LXA
- Generic Name
- Tissue graft of 6mm and greater
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 19, 1991
- Date Received
- December 24, 1990
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
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 |
|---|---|---|---|
| LXA | Tissue Graft Of 6mm And Greater | FDA class 3 | Unknown |