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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, MODELS 610130 AND 610131
Generic NameDevice, hemostasis, vascular
ApplicantTerumo Medical Corporation
950 Elkton Blvd.
Elkton, MD 21921
PMA NumberP930038
Supplement NumberS040
Date Received08/23/2004
Decision Date09/13/2004
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A NEW 9 HOLE, HOUR-GLASS SHAPE COLLAGEN SPONGE AND A COATED SUTURE WITH MINOR CHANGES TO THE CARRIER TUBE TO INCORPORATE THE COLLAGEN SPONGE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS, MODELS 610130 (6 FR.) AND 610131 (8 FR.).
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