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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 NumberS002
Date Received05/21/2001
Decision Date02/13/2002
Product Code MAD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE INOUE BALLOON CATHETER WHICH IS INDICATED FOR PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY IN PATIENTS WITH HEMODYNAMICALLY SIGNIFICANT MITRAL VALVULAR STENOSIS RESULTING PRIMARILY FROM COMMISSURAL FUSION OF THE MITRAL VALVE CUSPS.
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