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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameINOUE BALLOON CATHETER
Classification Namecatheter, percutaneous (valvuloplasty)
Generic Nameballoon valvuloplasty. percutaneous transvenous mitral commissurotomy(ptmc).
ApplicantTORAY INDUSTRIES (AMERICA), INC.
PMA NumberP910054
Date Received09/09/1991
Decision Date06/28/1994
Product Code
MAD[ Registered Establishments with MAD ]
Docket Number 94M-0269
Notice Date 08/25/1994
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S004 S005 
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