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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTORAY INOUE BALLON CATHETER
Classification Namecatheter, percutaneous (valvuloplasty)
Generic Namecatheter, percutaneous (valvuloplasty)
Applicant
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.
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