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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 NumberS001
Date Received05/22/1995
Decision Date11/30/1995
Product Code
MAD[ Registered Establishments with MAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification of the sterilization cycle.
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