TRIDYNE Vascular Sealant
FDA premarket approval P150016/S026 · decided 2025-06-18
Approval details
- PMA number
- P150016
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRIDYNE Vascular Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2025-05-30
- Decision date
- 2025-06-18
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- For the reduction of TM-0080 Particulate Testing for PEG Filled Cartridges (78-8110-3501-9) and to qualify an alternate supplier (Neomend, Inc.) to perform Sodium Concentration Testing (TM-0056 REV.1).
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