Catheters, Transluminal Coronary Angioplasty, Percutaneous
Basic Information
- Device Name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Trade Name
- NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER
- PMA Number
- P790017
- Supplement Number
- S079
- 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 4, 2003
- Date Received
- January 16, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO MAKE MODIFICATIONS TO THE STORMER BALLOON DILATATION CATHETER WITH ZIPPER DELIVERY. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES NC STORMER OVER-THE-WIRE BALLOON DILATATION CATHETER AND NC STORMER ZIPPER MX BALLOON DILATATION CATHETER AND ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE NC STORMER BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM - 4.0 MM) IS ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. NOTE: BENCH TESTING WAS CONDUCTED WITH THE NC STORMER BALLOON DILATATION CATHETER AND MARKETED BALLOON EXPANDABLE STENTS. CONSIDERATION WOULD BE TAKEN WHEN THE DEVICE IS USED WITH DIFFERENT MANUFACTURERS' STENTS DUE TO DIFFERENCES IN STENT DESIGN.
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 |