PMA P950020S052
- Device
- FLEXTOME CUTTING BALLOON DILATATION DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S052
- Decision date
- 2012-09-06
- Approval order statement
- USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.
Current openFDA PMA Record#
- Device
- FLEXTOME CUTTING BALLOON DILATATION DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S052
- Decision date
- 2012-09-06
- Decision code
- OK30
- Date received
- 2012-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF NEW STATISTICAL PROCESS CONTROL SOFTWARE.