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 | QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | SUB-Q, INC. 1062-D CALLE NEGOCIO SAN CLEMENTE, CA 92673 |
PMA Number | P010049 |
Supplement Number | S008 |
Date Received | 06/30/2003 |
Decision Date | 08/13/2003 |
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 TO MODIFY THE DEVICE TO REDUCE THE NUMBER OF PREPARATION STEPS, SIMPLIFY THE METHOD OF STAGING THE HEMOSTATIC SPONGE INTO DELIVERY CANNULA AND PROVIDE AN EASIER INTERFACE FOR FLUSHING THE DEPTH MARKER. |
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