FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Glue, Surgical, Arteries
PMA: P010003
·
Supplement: S002
·
Decision Oct 8, 2002
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
- S002
- 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 8, 2002
- Date Received
- September 19, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT CRYOLIFE, INC., KENNESAW, GEORGIA.
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 |