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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMINI BALLOON
Classification Namedevice, vascular, for promoting embolization
Generic Namedetachable balloon catheter system
Regulation Number870.3300
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
PMA NumberP780011
Date Received11/27/1978
Decision Date05/15/1980
Withdrawal Date 05/06/2009
Product Code
KRD[ Registered Establishments with KRD ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S004 S005 S006 S007 
S010 S011 S012 
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