PMA P910054S002

Device: INOUE BALLOON CATHETER
Applicant: Toray Industries (America), Inc.
PMA number: P910054
Supplement: S002
Product code: MAD
Decision date: 2002-02-13
Classification: Catheter, Percutaneous (valvuloplasty)
Generic name: CATHETER, PERCUTANEOUS (VALVULOPLASTY)
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.

Current openFDA PMA Record#

Device: INOUE BALLOON CATHETER
Applicant: Toray Industries (America), Inc.
PMA number: P910054
Supplement: S002
Product code: MAD
Generic name: CATHETER, PERCUTANEOUS (VALVULOPLASTY)
Decision date: 2002-02-13
Decision code: APPR
Date received: 2001-05-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.