PMA P950020S058
- Device
- CORONARY FLEXTOME CUTTING BALLON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S058
- Decision date
- 2012-12-13
- Approval order statement
- ADDITION OF ALTERNATE MANUFACTURING EQUIPMENT TO TEST FOR BALLOON LEAKS IN THE DEVICE.
Current openFDA PMA Record#
- Device
- CORONARY FLEXTOME CUTTING BALLON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S058
- Decision date
- 2012-12-13
- Decision code
- OK30
- Date received
- 2012-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF ALTERNATE MANUFACTURING EQUIPMENT TO TEST FOR BALLOON LEAKS IN THE DEVICE.