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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 NumberS005
Date Received04/19/2011
Decision Date05/17/2011
Product Code
MAD[ Registered Establishments with MAD ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a sterilizer at your seta plant facility.