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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 PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
Generic NameDevice, hemostasis, vascular
ApplicantTerumo Medical Corporation
950 Elkton Blvd.
Elkton, MD 21921
PMA NumberP930038
Supplement NumberS039
Date Received04/02/2004
Decision Date04/30/2004
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD LANGUAGE THAT INSTRUCTS THE USER IN THE METHOD ASSOCIATED WITH REPUNCTURE OF THE SAME LOCATION OF PREVIOUS ANGIO-SEAL USE WHEN THE PREVIOUS USE OCCURRED IN LESS THAN OR EQUAL TO 90 DAYS.
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