TRIDYNE Vascular Sealant
FDA premarket approval P150016/S012 · decided 2018-04-20
Approval details
- PMA number
- P150016
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRIDYNE Vascular Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2018-01-22
- Decision date
- 2018-04-20
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for updates to the performance specifications for Tridyne Vascular Sealant.
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