Catheter, Coronary, Atherectomy
Basic Information
- Device Name
- Catheter, Coronary, Atherectomy
- Trade Name
- ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM
- PMA Number
- P900056
- Supplement Number
- S024
- Device Class
- FDA Class 3
- Product Code
- MCX
- Generic Name
- CATHETER, CORONARY, ATHERECTOMY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 2, 1998
- Date Received
- August 11, 1998
- Supplement Type
- Real-Time Process
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval to provide the Rotablator(R) RotaLink system to the user in a pre-connected configuration. The device, as modified, will be marketed under the trade name Rotoblator(R) RotaLink Plus(TM) Rotational Angioplasty system and is indicated as a means of providng percutaneous rotational coronary angioplasty, as a sole therapy or with adjunctive balloon angioplasty, in patients with coronary artery disease who are candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria: 1) single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guide wire; 2) multiple vessel coronary artery disease that in the physician's judgment does not pose undue risk to the patient; 3) certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA), and who have a restenosis of the native vessel; or 4) native vessel atherosclerotic coronary artery disease that is less than 25mm in length.
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 |
|---|---|---|---|
| MCX | Catheter, Coronary, Atherectomy | FDA class 3 | Unknown |