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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 NumberS009
Date Received10/31/2023
Decision Date05/24/2024
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the use of packaging pouches with a change in the specification of a film component, the use of a new plasma welding machine for an accessory device, and the use of a new plating company for the plating of the hubs of device components.
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