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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/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.
 
DeviceINOUE BALLOON CATHETER
Generic NameCATHETER, PERCUTANEOUS (VALVULOPLASTY)
ApplicantToray Industries (America), Inc.
461 FIFTH AVENUE, 9TH FLOOR
NEW YORK, NY 10017
PMA NumberP910054
Date Received09/09/1991
Decision Date06/28/1994
Product Code MAD 
Docket Number 94M-0269
Notice Date 08/25/1994
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S004 S005 S006 S007 S008 
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