PMA P910054S006
- Device
- Toray Inoue Balloon Catheter
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S006
- Product code
- MAD
- Decision date
- 2018-09-13
- Classification
- Catheter, Percutaneous (valvuloplasty)
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Approval order statement
- Addition of new packaging heat sealing equipment.
Current openFDA PMA Record#
- Device
- Toray Inoue Balloon Catheter
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S006
- Product code
- MAD
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Decision date
- 2018-09-13
- Decision code
- OK30
- Date received
- 2018-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of new packaging heat sealing equipment.