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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 AVENUE, 9TH FLOOR
NEW YORK, NY 10017
PMA NumberP910054
Supplement NumberS001
Date Received05/22/1995
Decision Date11/30/1995
Product Code MAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION OF THE STERILIZATION CYCLE
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