Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | TRIDYNE Vascular Sealant |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P150016 |
Supplement Number | S006 |
Date Received | 10/23/2017 |
Decision Date | 11/29/2017 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacturing process and location change of DuPont’s production of Tyvek used in the manufacture of packaging material for the device. |
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