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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 NameINOUE BALLOON CATHETER
Classification Namecatheter, percutaneous (valvuloplasty)
Generic Nameballoon valvuloplasty
ApplicantTORAY INDUSTRIES (AMERICA), INC.
PMA NumberP910054
Supplement NumberS002
Date Received05/21/2001
Decision Date02/13/2002
Product Code
MAD[ Registered Establishments with MAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the inoue balloon catheter which is indicated for percutaneous transvenous mitral commissurotomy in patients with hemodynamically significant mitral valvular stenosis resulting primarily from commissural fusion of the mitral valve cusps.
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