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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(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantTerumo Medical Corporation
950 Elkton Blvd.
Elkton, MD 21921
PMA NumberP930038
Supplement NumberS005
Date Received04/16/1997
Decision Date05/01/1997
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE INDICATIONS FOR USE FOR THE ANGIO-SEAL(TM) DEVICE. THE ANGIO-SEAL(TM) HEMOSTATIC PUNCTURE CLOSURE DEVICE IS NOW INDICATED FOR USE IN CLOSING AND IN REDUCING TIME TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY OR INTERVENTIONAL PROCEDURES USING AN RETROGRADE APPROACH AND AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH.
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