FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Tissue Graft Of 6mm And Greater
PMA: P020049
·
Supplement: S002
·
Decision Mar 23, 2010
Classifications
1
FEI Numbers
3
Registration Numbers
3
Basic Information
- Device Name
- Tissue Graft Of 6mm And Greater
- Trade Name
- PROCOL VASCULAR BIOPROSTHESIS
- PMA Number
- P020049
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- LXA
- Generic Name
- Tissue graft of 6mm and greater
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 23, 2010
- Date Received
- February 22, 2010
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ADDITION OF A NEW DISTRIBUTION SITE.
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 |