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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 ARTERIAL CLOSURE SYSTEM WITH Q-FOAM
Generic NameDevice, hemostasis, vascular
ApplicantSub-Q, Inc.
1062-D Calle Negocio
San Clemente, CA 92673
PMA NumberP010049
Supplement NumberS001
Date Received04/08/2002
Decision Date09/16/2002
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN HEMOSTATIC MATERIAL FROM GELFOAM TO Q-FOAM.
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