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 | Cardiva VASCADE Family |
Generic Name | Device, hemostasis, vascular |
Applicant | CARDIVA MEDICAL, INC. 2900 LAKESIDE DRIVE SUITE 160 Santa Clara, CA 95054 |
PMA Number | P120016 |
Supplement Number | S031 |
Date Received | 11/30/2022 |
Decision Date | 12/29/2023 |
Product Code |
MGB |
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 the addition of four sterilization sites located at Sterigenics, U.S., LLC: 1700 College Blvd. West Memphis, AR 72301; 1003 Lakeside Drive Gurnee, IL 60031; 1401 Morgan Cir. Tustin, CA 92780; 3125 Wichita Court Fort Worth, TX 76140 |
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