Nir on TM Ranger TM Premounted Stent System
FDA premarket approval P980001 · Stent, Coronary
Approval
- Applicant
- Boston Scientific Corp
- Received
- January 28, 1998
- Decision date
- August 11, 1998 (APWD)
- Supplements
- 38, latest July 25, 2003
- Product code
- MAF – Stent, Coronary
Approval order 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.