Catheters, Transluminal Coronary Angioplasty, Percutaneous
Basic Information
- Device Name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Trade Name
- CUTTING BALLOON
- PMA Number
- P950020
- Supplement Number
- S006
- Device Class
- FDA Class 2
- Product Code
- LOX
- Generic Name
- Catheters, transluminal coronary angioplasty, percutaneous
- Regulation Number
- 870.5100
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 11, 2003
- Date Received
- June 28, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR: 1) USE OF THE BIOSLIDE COATING ON ALL CUTTING BALLOON MODELS, AND 2) USE OF A REVISED Y-SITE ON OVER-THE-WIRE (OTW) CUTTING BALLOON MODELS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON MONORAIL/OTW AND IS INDICATED FOR 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 POSSES 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | FDA class 2 | Cardiovascular |