PMA P950020S005

Device

CUTTING BALLOON

Applicant

Boston Scientific Corp

PMA number

P950020

Supplement

S005

Product code

LOX

Decision date

2002-07-17

Classification

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Generic name

Catheters, transluminal coronary angioplasty, percutaneous

Approval order statement

APPROVAL FOR THE 6 MM CUTTING BALLOON. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON MONORAIL/OTW (6 MM) AND IS INDICATED FOR DILATATION OF STENOSIS 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 FOLLOWING 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.