PMA P950020S053
- Device
- FLEXTOME CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S053
- Decision date
- 2012-09-07
- Approval order statement
- AN ALTERNATE SUPPLIER FOR THE BALLOON PROTECTOR CAP COMPONENT; AND MINOR DIMENSIONAL CHANGES FOR THE BALLOON PROTECTOR CAP COMPONENT.
Current openFDA PMA Record#
- Device
- FLEXTOME CUTTING BALLOON
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S053
- Decision date
- 2012-09-07
- Decision code
- OK30
- Date received
- 2012-08-16
- Supplement type
- 30-Day Notice
- Approval order statement
- AN ALTERNATE SUPPLIER FOR THE BALLOON PROTECTOR CAP COMPONENT; AND MINOR DIMENSIONAL CHANGES FOR THE BALLOON PROTECTOR CAP COMPONENT.