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 | S010 |
Date Received | 11/29/2017 |
Decision Date | 09/12/2018 |
Product Code |
NBE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for alternate sterilization sites located at Bard Regional Sterilization, 1211 Mary Magnum Boulevard, Madison, Georgia and Bard Regional Sterilization, 8195 Industrial Boulevard, Covington, Georgia. |
|
|