FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Glue, Surgical, Arteries
PMA: P010003
·
Decision Dec 3, 2001
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Glue, Surgical, Arteries
- Trade Name
- BIOGLUE SURGICAL ADHESIVE
- PMA Number
- P010003
- Device Class
- FDA Class 3
- Product Code
- MUQ
- Generic Name
- Glue, surgical, arteries
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 3, 2001
- Date Received
- February 2, 2001
- Expedited Review
- N
- Docket Number
- 01M-0567
Advisory Committee Statement
APPROVAL FOR THE BIOFLUE SURGICAL ADHESIVE. THIS DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO STANDARD METHODS OF ACHIEVING HEMOSTASIS (SUCH AS SUTURES AND STAPLES) IN ADULT PATIENTS IN OPEN SURGICAL REPAIR OF LARGE VESSELS (SUCH AS AORTA, FEMORAL AND CAROTID ARTERIES).
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 |
|---|---|---|---|
| MUQ | Glue, Surgical, Arteries | FDA class 3 | Unknown |