Drug Eluting Stent - India CDSCO Medical Device Registration

Drug Eluting Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000511_02c065524b5d157cdf1cefa54280210d_3cebcc1e77f665e6d04ab397c6524cf9. This device is marketed under the brand name Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Drug Eluting Stent

UID: IMP/MD/2019/000511_02c065524b5d157cdf1cefa54280210d_3cebcc1e77f665e6d04ab397c6524cf9

Brand Name

Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System

License Holder

Abbott Healthcare Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The XIENCE PRIME, XIENCE PRIME SV, and XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems are indicated for improving coronary luminal diameter in the following: • Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. • For restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. • For the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System); for the treatment of elderly patients (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System), and for treatment of both men and women. • For the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System); and coronary artery bifurcation lesions. In all cases, the treated lesion length should be less than the nominal stent length (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with a reference vessel diameter of ≥ 2.25 mm and ≤ 4.25 mm

Class D

Drug Eluting Stent

Brand: Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System

Abbott Healthcare Private Limited

Class D

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Class B

Brand: Xience Alpine™ Everolimus Eluting Coronary Stent System

Class D