Catheters, Transluminal Coronary Angioplasty, Percutaneous
Basic Information
- Device Name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Trade Name
- SPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)
- PMA Number
- P790017
- Supplement Number
- S081
- 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
- June 23, 2004
- Date Received
- December 26, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MINOR DESIGN, PACKAGING AND LABELING CHANGES TO THE STORMER OTW BALLON DILATATION CATHETER INCLUDING THE ADDITION OF 6 MM AND 12 MM BALLOON LENGTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPRINTER OTW BALLOON DILATATION CATHETER AND IS INDICATED AS FOLLOWS: FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. THE SPRINTER OTW BALLOON DILATATION CATHETER (BALLOON MODELS 2.5 MM - 4.0 MM) IS ALSO INDICATED FOR POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS. NOTE: BENCH TESTING WAS CONDUCTED WITH THE SPRINTER OTW BALLOON DILATATION CATHETER AND MARKETED BALLOON EXPANDABLE STENTS. CONSIDERATION SHOULD BE TAKEN WHEN THIS 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 |