FDA Premarket Approval P910054 S008

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.

Pre-market Approval Supplement Details

Change to the location of the supplier of latex tube components.

DeviceINOUE-BALLOON Catheter
Generic NameCatheter, Percutaneous (valvuloplasty)
ApplicantToray Industries (America), Inc.
Date Received2021-08-13
Decision Date2021-08-31
Product CodeMAD 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Toray Industries (America), Inc. 461 Fifth Avenue, 9th Floor new York, NY 10017

Supplemental Filings

Supplement NumberDateSupplement Type
P910054Original Filing
S008 2021-08-13 30-day Notice
S007 2020-03-04 30-day Notice
S006 2018-09-04 30-day Notice
S005 2011-04-19 30-day Notice
S004 2006-11-15 135 Review Track For 30-day Notice
S002 2001-05-21 Normal 180 Day Track
S001 1995-05-22 Normal 180 Day Track

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