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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.
 
DeviceMINI BALLOON
Generic NameDevice, Vascular, for Promoting Embolization
Regulation Number870.3300
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
ONE BECTON DR.
FRANKLIN LAKES, NJ 07417-1880
PMA NumberP780011
Supplement NumberS012
Date Received08/29/1989
Decision Date10/30/1989
Withdrawal Date 05/06/2009
Product Code KRD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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