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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 NumberS005
Date Received02/21/2003
Decision Date03/12/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR TWO LABELING ADDITIONS TO THE APPROVED PREMARKET APPROVAL APPLICATION.
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