|Approval Order Statement |
Approval to implement new orthogonal methods to quantitate drug content, impurities and degradation products for the cypher stent. Based upon these new methods, you have also requested approval for new specifications for impurities and degradation products for the cypher stent at finished goods release testing and on stability. The device, as modified, will be marketed under the trade name cypher sirolimus-eluting coronary stent on the raptor over-the-wire delivery system or raptorrail rapid exchange delivery system and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length <= 30mm in native coronary arteries with reference vessel diameter of >= 2. 5 mm to <= 3. 5 mm.