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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 NumberS002
Date Received03/21/1997
Decision Date04/25/1997
Product Code MGB 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES
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