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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
Classification Namedevice, vascular, for promoting embolization
Generic Namedevice, embolization, arterial
Regulation Number870.3300
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
PMA NumberP780011
Supplement NumberS010
Date Received05/01/1987
Decision Date01/29/1988
Product Code
KRD[ Registered Establishments with KRD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
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