FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Glue, Surgical, Arteries
PMA: P010003
·
Supplement: S031
·
Decision Nov 1, 2018
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
- S031
- 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
- November 1, 2018
- Date Received
- October 2, 2018
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for changes 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 |