PMA P910054S008
- Device
- INOUE-BALLOON Catheter
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S008
- Product code
- MAD
- Decision date
- 2021-08-31
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Approval order statement
- Change to the location of the supplier of latex tube components.
Current openFDA PMA Record#
- Device
- INOUE-BALLOON Catheter
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S008
- Product code
- MAD
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Decision date
- 2021-08-31
- Decision code
- OK30
- Date received
- 2021-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the location of the supplier of latex tube components.