PMA P950020S056
- Device
- CORONARY FLEXTOME CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S056
- Decision date
- 2012-10-31
- Approval order statement
- A SECOND PROXIMAL BOND LASER AND SEVERAL PROCESS CHANGES TO THE AUTOMATIC TORCH BOX.
Current openFDA PMA Record#
- Device
- CORONARY FLEXTOME CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S056
- Decision date
- 2012-10-31
- Decision code
- OK30
- Date received
- 2012-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- A SECOND PROXIMAL BOND LASER AND SEVERAL PROCESS CHANGES TO THE AUTOMATIC TORCH BOX.