PMA P950020S044
- Device
- FLEXTOME CUTTING BALLOON DILATATION DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S044
- Decision date
- 2011-06-30
- Approval order statement
- IMPLEMENTATION OF THE USE OF A CLOSED-LOOP CONTROL (FEEDBACK), IN THE EXTRUSION OF THE TIE LAYER OF THE TRI-LAYER COMPONENT.
Current openFDA PMA Record#
- Device
- FLEXTOME CUTTING BALLOON DILATATION DEVICE
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S044
- Decision date
- 2011-06-30
- Decision code
- OK30
- Date received
- 2011-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF THE USE OF A CLOSED-LOOP CONTROL (FEEDBACK), IN THE EXTRUSION OF THE TIE LAYER OF THE TRI-LAYER COMPONENT.