PMA P910054S007
- Device
- Inoue Balloon Catheter
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S007
- Product code
- MAD
- Decision date
- 2020-03-30
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Approval order statement
- Change to the raw material of the dilator accessory.
Current openFDA PMA Record#
- Device
- Inoue Balloon Catheter
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S007
- Product code
- MAD
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Decision date
- 2020-03-30
- Decision code
- OK30
- Date received
- 2020-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the raw material of the dilator accessory.