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; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P150016 |
Supplement Number | S009 |
Date Received | 11/28/2017 |
Decision Date | 08/10/2018 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to implement changes to the human serum albumin (HSA) filling and polyethylene glycol (PEG) filling processes. |
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