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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceQUICKSEAL CCS ARTERIAL CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantSub-Q, Inc.
1062-D Calle Negocio
San Clemente, CA 92673
PMA NumberP010049
Supplement NumberS002
Date Received04/22/2002
Decision Date06/13/2002
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR EXTENDING THE SHELF LIFE OF THE APPROVED QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM FROM 6 TO 24 MONTHS.
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