Catheters, Transluminal Coronary Angioplasty, Percutaneous
Basic Information
- Device Name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Trade Name
- CUTTING BALLOON MONORAIL
- PMA Number
- P950020
- Supplement Number
- S004
- 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
- February 15, 2002
- Date Received
- September 17, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A RAPID EXCHANGE VERSION OF THE CUTTING BALLOON. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON MONORAIL 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 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 ANTIOGRAPHIC 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 |