Flexatome Cutting Balloon

FDA premarket approval P950020 · Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

PMA numberP950020

Approval

Applicant
Boston Scientific Corp
Received
June 26, 1995
Decision date
April 18, 2000 (APPR)
Supplements
139, latest January 27, 2026
Product code
NWX – Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

Official FDA PMA record

Approval order statement

THIS DEVICE IS INDICATED FOR THE DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED. IN ADDITION, THE TARGET LESION SHOULD POSSESS THE FILLOWING CHARACTERISTICS: DISCRETE (<=15 MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH) WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.0 MM TO 4.0 MM; READILY ACCESSIBLE TO THE DEVICE; LIGHT TO MODERATE TORTUOSITY OF PROXIMAL VESSEL SEGMENT, NON-ANGULATED LESION SEGMENT (<45 DEGREES), SMOOTH ANGIOGRAPHIC CONTOUR; AND ABSENCE OF ANGIOGRAPHICALLY-VISIBLE THROMBUS AND/OR CALCIFICATION.