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. |
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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 |
Supplement Number | S010 |
Date Received | 05/01/1987 |
Decision Date | 01/29/1988 |
Withdrawal Date
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05/06/2009 |
Product Code |
KRD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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