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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 NameTORAY INOUE BALLON CATHETER
Classification Namecatheter, percutaneous (valvuloplasty)
Generic Nameballoon valvuloplasty
ApplicantTORAY INDUSTRIES (AMERICA), INC.
PMA NumberP910054
Supplement NumberS004
Date Received11/15/2006
Decision Date07/03/2007
Product Code
MAD[ Registered Establishments with MAD ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the supplier of the guidewire and stylet bulk material.
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