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 | VASCADE VASCULAR CLOSURE SYSTEM (VCS) |
Generic Name | Device, hemostasis, vascular |
Applicant | CARDIVA MEDICAL, INC. 2900 LAKESIDE DRIVE SUITE 160 Santa Clara, CA 95054 |
PMA Number | P120016 |
Supplement Number | S015 |
Date Received | 05/18/2015 |
Decision Date | 07/08/2015 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE DEPLOYMENT FORCE PERFORMANCE SPECIFICATION FOR THE VASCADE 5F AND 6/7F DEVICE. |
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