TRIDYNE Vascular Sealant
FDA premarket approval P150016/S006 · decided 2017-11-29
Approval details
- PMA number
- P150016
- Supplement
- S006
- 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
- 2017-10-23
- Decision date
- 2017-11-29
- Days to decision
- 37 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Manufacturing process and location change of DuPonts production of Tyvek used in the manufacture of packaging material for the device.
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