FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Glue, Surgical, Arteries
PMA: P010003
·
Supplement: S041
·
Decision Oct 20, 2023
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
- S041
- 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
- October 20, 2023
- Date Received
- September 20, 2023
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for an additional caution statement regarding use of the device in aortic dissection surgery and other minor updates to the Instructions for Use.
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 |