Catheters, Transluminal Coronary Angioplasty, Percutaneous
Basic Information
- Device Name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Trade Name
- ACS RX COMET VP (TM) CORONARY DILATATION CATHETER/HYDROCOAT HYDROPHILIC
- PMA Number
- P810046
- Supplement Number
- S185
- 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 8, 1998
- Date Received
- January 20, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for an additional balloon length, the addition of HYDROCOAT(TM) hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and hydrophilic coating, a change in the sterilization method and packaging and an increase in the rated ubrst pressure for the 3.25mm through 4.0mm balloon diameters. The device as modified, will be marketed under the trade name ACS RX Comet VP(TM) Coronary Dilatation Catheters with HYDROCOAT(TM) Hydrophilic coating and is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improvng myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purose of restoring coronary flow in patients with ST-segment elevation yocardial infarction.
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 |