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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 NumberS006
Date Received03/24/2003
Decision Date04/24/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO LENGTHEN THE APPROVED GUIDEWIRE FROM 55 CM TO 70 CM.
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