PMA P910054S004
- Device
- TORAY INOUE BALLON CATHETER
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S004
- Product code
- MAD
- Decision date
- 2007-07-03
- Classification
- Catheter, Percutaneous (valvuloplasty)
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Approval order statement
- APPROVAL FOR A CHANGE TO THE SUPPLIER OF THE GUIDEWIRE AND STYLET BULK MATERIAL.
Current openFDA PMA Record#
- Device
- TORAY INOUE BALLON CATHETER
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S004
- Product code
- MAD
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Decision date
- 2007-07-03
- Decision code
- APPR
- Date received
- 2006-11-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO THE SUPPLIER OF THE GUIDEWIRE AND STYLET BULK MATERIAL.