FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Glue, Surgical, Arteries
PMA: P010003
·
Supplement: S024
·
Decision Jul 7, 2016
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
- S024
- Device Class
- FDA Class 3
- Product Code
- MUQ
- Generic Name
- Glue, surgical, arteries
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- July 7, 2016
- Date Received
- June 14, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change in the sampling plan used for BioGlue Surgical Adhesive testing.
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 |