TRIDYNE VASCULAR SEALANT
FDA premarket approval P150016/S005 · decided 2017-07-06
Approval details
- PMA number
- P150016
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRIDYNE VASCULAR SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2017-04-10
- Decision date
- 2017-07-06
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval to modify the storage conditions of Tridyne Vascular Sealant (Tridyne VS) from refrigerated conditions 2-8°C (36-46°F) to include a controlled ambient temperature storage excursion of 8-25°C (46-77°F) for a period of up to 35 days within the approved shelf life of 24 months.
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