TRIDYNE VASCULAR SEALANT
FDA premarket approval P150016/S003 · decided 2016-11-29
Approval details
- PMA number
- P150016
- Supplement
- S003
- 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
- 2016-10-25
- Decision date
- 2016-11-29
- Days to decision
- 35 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Add particulate matter checks at various stages of the Tridyne Vascular Sealant manufacturing process.
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