PMA P950020S112

Device: Wolverine Coronary Cutting Balloon
Applicant: Boston Scientific Corp
Product code: NWX
Decision date: 2021-11-02
Generic name: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Approval order statement: Approval for updates to the IFU Intended Use/Indications for Use section to remove the restriction on treatment of calcified lesions, and to revise the warning in relation to emergency surgery availability.

Current openFDA PMA Record#

Device: Wolverine Coronary Cutting Balloon
Applicant: Boston Scientific Corp
PMA number: P950020
Supplement: S112
Product code: NWX
Generic name: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Decision date: 2021-11-02
Decision code: APPR
Date received: 2021-08-04
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to the IFU Intended Use/Indications for Use section to remove the restriction on treatment of calcified lesions, and to revise the warning in relation to emergency surgery availability.