PMA P910054S009

Device: Inoue-Balloon Catheter
Applicant: Toray Industries (America), Inc.
PMA number: P910054
Supplement: S009
Product code: MAD
Decision date: 2024-05-24
Classification: Cardiovascular
Generic name: CATHETER, PERCUTANEOUS (VALVULOPLASTY)
Approval order statement: approval for the use of packaging pouches with a change in the specification of a film component, the use of a new plasma welding machine for an accessory device, and the use of a new plating company for the plating of the hubs of device components.

Current openFDA PMA Record#

Device: Inoue-Balloon Catheter
Applicant: Toray Industries (America), Inc.
PMA number: P910054
Supplement: S009
Product code: MAD
Generic name: CATHETER, PERCUTANEOUS (VALVULOPLASTY)
Decision date: 2024-05-24
Decision code: APPR
Date received: 2023-10-31
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the use of packaging pouches with a change in the specification of a film component, the use of a new plasma welding machine for an accessory device, and the use of a new plating company for the plating of the hubs of device components.