PMA P950020S141

Device: FLEXATOME CUTTING BALLOON
Applicant: Boston Scientific Corp
PMA number: P950020
Supplement: S141
Product code: NWX
Decision date: 2023-10-30
Classification: Cardiovascular
Generic name: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Approval order statement: Approval for modifications to the labeling, minor changes to the physical packaging, and updates to the design documentation.

Current openFDA PMA Record#

Device: FLEXATOME CUTTING BALLOON
Applicant: Boston Scientific Corp
PMA number: P950020
Supplement: S141
Product code: NWX
Generic name: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Decision date: 2023-10-30
Decision code: APPR
Date received: 2023-08-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the labeling, minor changes to the physical packaging, and updates to the design documentation.