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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 HEMOSTATIC PUNCTURE CLOSURE DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantTERUMO MEDICAL CORPORATION
950 ELKTON BLVD.
ELKTON, MD 21921
PMA NumberP930038
Supplement NumberS019
Date Received06/28/1999
Decision Date03/08/2000
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the 6F Angio-Seal(TM) Hemostatic Puncture Closure Device. The device, as modified, will be marketed under the trade name 6F Angio-Seal(TM) Hemostatic Puncture Closure Device and is indicated for closing the femoral arterial puncture site in patients who have undergone diagnostic angiography procedures using a retrograde approach and a 6 French or smaller procedureal sheath. The Angio-Seal (TM) device reduces the times to hemostasis, ambulation and discharge in patients who have undergone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations).
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