Identity
- Trade Name
- TRIDYNE VASCULAR SEALANT FDA PMA
- Generic Name
- Sealant, polymerizing FDA PMA
Identifiers
- PMA Number
- P150016 FDA PMA
- FDA Product Code
- NBE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Tridyne Vascular Sealant is a polymerizing sealant designed for use in aortic surgery. It functions as an adjunctive measure to achieve hemostasis by mechanically sealing areas of leakage during surgical procedures.
This device is manufactured by Neomend, Inc. and is authorized under FDA PMA number P150016. It is categorized as a class 3 medical device.
Frequently asked questions
What is the primary indication for the Tridyne Vascular Sealant?
The Tridyne Vascular Sealant is indicated for use specifically in aortic surgery. It is intended to be used as an adjunctive measure to help achieve hemostasis by mechanically sealing areas where leakage occurs.
What type of device is the Tridyne Vascular Sealant?
The Tridyne Vascular Sealant is classified as a polymerizing sealant. It is a class 3 medical device regulated under the FDA PMA pathway.
Who is the manufacturer of this vascular sealant?
The Tridyne Vascular Sealant is manufactured by Neomend, Inc., which is based in Irvine, California.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150016 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neomend, Inc.
Sources (1)
- FDA PMA P150016 24 fields · synced Sep 18, 2026