FDA.reportPublic FDA data

PMA P950020S133

Device
Wolverine Coronary Cutting Balloon
Applicant
Boston Scientific Corp
Product code
NWX
Decision date
2023-03-02
Generic name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Approval order statement
Approval for a change to approve an alternate supplier of an equivalent resin used as the middle layer in the tri-layer inner component of your stents’ delivery system.

Current openFDA PMA Record#

Device
Wolverine Coronary Cutting Balloon
Applicant
Boston Scientific Corp
PMA number
P950020
Supplement
S133
Product code
NWX
Generic name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Decision date
2023-03-02
Decision code
APPR
Date received
2022-12-07
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a change to approve an alternate supplier of an equivalent resin used as the middle layer in the tri-layer inner component of your stents’ delivery system.