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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.
 
DeviceINOUE BALLOON CATHETER
Generic NameCATHETER, PERCUTANEOUS (VALVULOPLASTY)
ApplicantToray Industries (America), Inc.
461 Fifth Ave.
9th Floor
New York, NY 10017
PMA NumberP910054
Supplement NumberS010
Date Received06/03/2024
Decision Date07/01/2024
Product Code MAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change in the production line (spinning mill) for the polyester yarn used in the mesh portion of the Inoue-Balloon Catheter
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