PMA P910054S001
- Device
- INOUE BALLOON CATHETER
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S001
- Product code
- MAD
- Decision date
- 1995-11-30
- Classification
- Catheter, Percutaneous (valvuloplasty)
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Approval order statement
- APPROVAL FOR A MODIFICATION OF THE STERILIZATION CYCLE
Current openFDA PMA Record#
- Device
- INOUE BALLOON CATHETER
- Applicant
- Toray Industries (America), Inc.
- PMA number
- P910054
- Supplement
- S001
- Product code
- MAD
- Generic name
- CATHETER, PERCUTANEOUS (VALVULOPLASTY)
- Decision date
- 1995-11-30
- Decision code
- APPR
- Date received
- 1995-05-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MODIFICATION OF THE STERILIZATION CYCLE