FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Sealant, Polymerizing
PMA: P150016
·
Supplement: S027
·
Decision Dec 18, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Sealant, Polymerizing
- Trade Name
- TRIDYNE Vascular Sealant
- PMA Number
- P150016
- Supplement Number
- S027
- Device Class
- FDA Class 3
- Product Code
- NBE
- Generic Name
- Sealant, polymerizing
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 18, 2025
- Date Received
- November 26, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
to reduce the testing frequencies of three tests for the TRIDYNE Vascular Sealant and the PROGEL Pleural Air Leak Sealant
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 |
|---|---|---|---|
| NBE | Sealant, Polymerizing | FDA class 3 | Unknown |