FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Glue, Surgical, Arteries
PMA: P010003
·
Supplement: S010
·
Decision Jun 7, 2007
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Glue, Surgical, Arteries
- Trade Name
- BIOGLUE SURGICAL ADHESIVE
- PMA Number
- P010003
- Supplement Number
- S010
- 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
- June 7, 2007
- Date Received
- April 20, 2007
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF A NON-STERILE, REUSABLE SYRINGE DELIVERY DEVICE.
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 |