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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 STS PLUS PLATFORM
Generic NameDevice, hemostasis, vascular
ApplicantTERUMO MEDICAL CORPORATION
950 ELKTON BLVD.
ELKTON, MD 21921
PMA NumberP930038
Supplement NumberS035
Date Received11/20/2002
Decision Date12/20/2002
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE INSERTION SHEATH (ADDITION OF PUNCTURE HOLES), GUIDEWIRE (INCREASE GUIDEWIRE SIZE FOR THE 6FR. DEVICE), PUNCTURE LOCATOR (MOVE LOCATOR HOLES, LABEL LOCATION (MOVE TO OUTSIDE OF PACKAGE) AND THE INSTRUCTIONS FOR USE (REVISE LABELING TO INCLUDE NEW INSTRUCTIONS RELATED TO THESE DESIGN CHANGES).
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