TRIDYNE VASCULAR SEALANT
FDA premarket approval P150016 · decided 2016-04-11
Approval details
- PMA number
- P150016
- Trade name
- TRIDYNE VASCULAR SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2015-04-27
- Decision date
- 2016-04-11
- Days to decision
- 350 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- The Tridyne Vascular Sealant is indicated for use in aortic surgery when adjunctive measures to achieve hemostasis are required by mechanically sealing areas of leakage.
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