PMA P950020S050

Device
CORONARY FLEXTOME CUTTING BALLOON
Applicant
Boston Scientific Corp
PMA number
P950020
Supplement
S050
Decision date
2012-06-18
Approval order statement
PROCESS CHANGE AND RELOCATION FOR PROXIMAL CATHETER MARKING.

Current openFDA PMA Record#

Device
CORONARY FLEXTOME CUTTING BALLOON
Applicant
Boston Scientific Corp
PMA number
P950020
Supplement
S050
Decision date
2012-06-18
Decision code
OK30
Date received
2012-05-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
PROCESS CHANGE AND RELOCATION FOR PROXIMAL CATHETER MARKING.