Tridyne Vascular Sealant
FDA premarket approval P150016/S010 · decided 2018-09-12
Approval details
- PMA number
- P150016
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tridyne Vascular Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2017-11-29
- Decision date
- 2018-09-12
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for alternate sterilization sites located at Bard Regional Sterilization, 1211 Mary Magnum Boulevard, Madison, Georgia and Bard Regional Sterilization, 8195 Industrial Boulevard, Covington, Georgia.
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