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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 II ARTERIAL CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantSUB-Q, INC.
1062-D CALLE NEGOCIO
SAN CLEMENTE, CA 92673
PMA NumberP010049
Supplement NumberS004
Date Received11/29/2002
Decision Date02/10/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY THE DESIGN OF THE DEPTH MARKET COMPONENT AND ELONGATE THE EXISTING CAVITY IN THE TRAY TO ACCOMMODATE THE DEPTH MARKET MODIFICATION.
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