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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 Balloon Catheter
Generic NameCATHETER, PERCUTANEOUS (VALVULOPLASTY)
ApplicantToray Industries (America), Inc.
461 Fifth Ave.
9th Floor
New York, NY 10017
PMA NumberP910054
Supplement NumberS006
Date Received09/04/2018
Decision Date09/13/2018
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  
Addition of new packaging heat sealing equipment.
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