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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.
 
DeviceANGIO-SEAL VASCULAR CLOSURE DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantTERUMO MEDICAL CORPORATION
950 ELKTON BLVD.
ELKTON, MD 21921
PMA NumberP930038
Supplement NumberS052
Date Received12/28/2007
Decision Date09/26/2008
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR USE OF THE ANGIO-SEAL VASCULAR CLOSURE DEVICE IN CLOSURE OF FEMORAL VENOUS PUNCTURE SITES AND FOR THE REMOVAL OF THE PRECAUTION STATEMENT RELATING TO THE USE OF THE ANTICOAGULANT WARFARIN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL AND FEMORAL VENOUS PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH.
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