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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.
Classification Namecatheter, percutaneous (valvuloplasty)
Generic Namecatheter, percutaneous (valvuloplasty)
Toray Industries (America), Inc.
461 fifth avenue, 9th floor
new york, NY 10017
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 - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the supplier of the guidewire and stylet bulk material.