HSA · registration DE0508674Abbott Medical XIENCE Skypoint Everolimus Eluting Coronary Stent System
- Registration number
- DE0508674
- Model name
- XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint; XIENCE Skypoint
- Model identifier
- 1800200-08; 1800200-12; 1800200-15; 1800200-18; 1800200-23; 1800200-28; 1800200-33; 1800200-38; 1800225-08; 1800225-12; 1800225-15; 1800225-18; 1800225-23; 1800225-28; 1800225-33; 1800225-38; 1800250-08; 1800250-12; 1800250-15; 1800250-18; 1800250-23; 1800250-28; 1800250-33; 1800250-38; 1800250-48; 1800275-08; 1800275-12; 1800275-15; 1800275-18; 1800275-23; 1800275-28; 1800275-33; 1800275-38; 1800275-48; 1800300-08; 1800300-12; 1800300-15; 1800300-18; 1800300-23; 1800300-28; 1800300-33; 1800300-38; 1800300-48; 1800325-08; 1800325-12; 1800325-15; 1800325-18; 1800325-23; 1800325-28; 1800325-33; 1800325-38; 1800350-08; 1800350-12; 1800350-15; 1800350-18; 1800350-23; 1800350-28; 1800350-33; 1800350-38; 1800350-48; 1800400-08; 1800400-12; 1800400-15; 1800400-18; 1800400-23; 1800400-28; 1800400-33; 1800400-38; 1800400-48; 1800450-12; 1800450-15; 1800450-18; 1800450-23; 1800450-28; 1800450-33; 1800500-12; 1800500-15; 1800500-18; 1800500-23; 1800500-28; 1800500-33
- Registration date
- November 17, 2023
- Risk class
- Class D
- Product owner
- Abbott Medical
- Registrant / registration holder
- ABBOTT MEDICAL (SINGAPORE), PTE. LTD.
Indicated for improving coronary artery 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, lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches; for the treatment of elderly patients (age ≥ 65), and for treatment of both men and women • For treatment of patients with high bleeding risk under dual anti-platelet therapy as short as 28 days • For the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions, coronary artery bifurcation lesions and • Left main coronary artery lesions for lengths up to 38mm
- Product owner address
- 3200 Lakeside Drive, Santa Clara, CA 95054, United States
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.