Stent, Coronary
Basic Information
- Device Name
- Stent, Coronary
- Trade Name
- NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM
- PMA Number
- P980001
- Device Class
- FDA Class 3
- Product Code
- MAF
- Generic Name
- STENT, CORONARY
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- August 11, 1998
- Date Received
- January 28, 1998
- Expedited Review
- N
- Docket Number
- 99M-1696
Advisory Committee Statement
approval for the NIR ON(TM) Ranger(TM) and NIR ON(TM) Ranger(TM) w/SOX(TM) Premounted Stent Systems. The device is indicated for improving coronary luminal diamter in the following patient subsets: a)patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length <25 mm) with a reference vessel diameter of 3.0 to 4.0 mm; b) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2.5 to 4.0 mm; c) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with lesion length < 30 mm and reference vessel diamter in the range of 3.0 to 4.0mm.
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 |
|---|---|---|---|
| MAF | Stent, Coronary | FDA class 3 | Unknown |