FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Tissue Graft Of 6mm And Greater
PMA: N16837
·
Supplement: S008
·
Decision Jan 10, 2012
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Tissue Graft Of 6mm And Greater
- Trade Name
- ARTEGRAFT COLLAGEN VASCULAR GRAFT
- PMA Number
- N16837
- Supplement Number
- S008
- 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
- January 10, 2012
- Date Received
- September 20, 2011
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
UPDATING OF THE STERILANT ETHYLENE OXIDE RESIDUAL PARAMETER.
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 |