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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 NumberS084
Date Received02/24/2017
Decision Date03/29/2017
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of one specification and three in-process inspections related to the device coating.
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