PMA P910054
- Device
- INOUE BALLOON CATHETER
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S008
- Product code
- MAD
- Decision date
- 2024-07-01
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Approval order statement
- a change in the production line (spinning mill) for the polyester yarn used in the mesh portion of the Inoue-Balloon Catheter
Current openFDA PMA Record#
- Device
- INOUE BALLOON CATHETER
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S010
- Product code
- MAD
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Decision date
- 2024-07-01
- Decision code
- OK30
- Date received
- 2024-06-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the production line (spinning mill) for the polyester yarn used in the mesh portion of the Inoue-Balloon Catheter