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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 NumberS003
Date Received11/15/2002
Decision Date11/27/2002
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY TO PERFORM DEVICE ASSEMBLY AND PACKAGING, LOCATED AT SUB-Q, INC., SAN CLEMENTE, CALIFORNIA.
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