TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip
FDA premarket approval P150016/S009 · decided 2018-08-10
Approval details
- PMA number
- P150016
- Supplement
- S009
- Supplement type
- 135 Review Track For 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
- 2018-08-10
- Days to decision
- 255 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval to implement changes to the human serum albumin (HSA) filling and polyethylene glycol (PEG) filling processes.
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