PMA P950020S054
- Device
- FLEXTOME CUTTING BALLOON DILATATION DEVICE (MONORAIL & OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S054
- Decision date
- 2012-09-21
- Approval order statement
- USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
Current openFDA PMA Record#
- Device
- FLEXTOME CUTTING BALLOON DILATATION DEVICE (MONORAIL & OVER-THE-WIRE)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S054
- Decision date
- 2012-09-21
- Decision code
- OK30
- Date received
- 2012-09-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.