Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | MINI BALLOON |
Generic Name | Device, Vascular, for Promoting Embolization |
Regulation Number | 870.3300 |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. FRANKLIN LAKES, NJ 07417-1880 |
PMA Number | P780011 |
Date Received | 11/27/1978 |
Decision Date | 05/15/1980 |
Withdrawal Date
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05/06/2009 |
Product Code |
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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