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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMINI-BALLOON DETACHABLE BALLOON SYSTEM
Classification Namedevice, vascular, for promoting embolization
Generic Namevascular occlusion device
Regulation Number870.3300
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
PMA NumberP780011
Supplement NumberS001
Date Received02/26/1981
Decision Date11/27/1981
Product Code
KRD[ Registered Establishments with KRD ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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