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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.
 
DeviceSURESTAT ARTERIAL CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantSub-Q, Inc.
1062-D Calle Negocio
San Clemente, CA 92673
PMA NumberP010049
Supplement NumberS012
Date Received07/19/2004
Decision Date08/31/2004
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 ADD A POLYSACCHARIDE (CHITOSAN) TO THE HEMOSTATIC PLEDGET FORMULATION AND REQUESTED TO RENAME THE DEVICE FROM THE QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM TO THE SURESTAT ARTERIAL CLOSURE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SURESTAT ARTERIAL CLOSURE SYSTEM AND IS INDICATED FOR "DELIVERY OF T-FOAM FOR EXTRAVASCULAR CLOSURE OF THE FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMALLER PROCEDURAL SHEATHS. THE DEVICE REDUCES TIME TO ELIGIBILITY FOR HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES AND REDUCES TIME TO ACTUAL HOSPITAL DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES."
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