TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip
FDA premarket approval P150016/S007 · decided 2017-12-20
Approval details
- PMA number
- P150016
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip
- Generic name
- Sealant, polymerizing
- Applicant
- Neomend, Inc.
- Date received
- 2017-11-28
- Decision date
- 2017-12-20
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Changes to the processing of the Human Serum Albumin (HSA) and Polyethylene Glycol (PEG) components of the Tridyne Vascular Sealant.
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