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. |
|
Device | TRIDYNE™ Vascular Sealant |
Generic Name | Sealant, polymerizing |
Applicant | NEOMEND, INC. 60 TECHNOLOGY DR. IRVINE, CA 92618 |
PMA Number | P150016 |
Supplement Number | S024 |
Date Received | 01/31/2024 |
Decision Date | 03/05/2024 |
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 to change the incoming component embedded particulate specification for the Chemistry Kit Lids and Trays for the PROGEL Pleural Air Leak Sealant and the TRIDYNE Vascular Sealant devices |
|
|