XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary
FDA premarket approval P110019/S115 · decided 2021-06-25
Approval details
- PMA number
- P110019
- Supplement
- S115
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2020-12-28
- Decision date
- 2021-06-25
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- Approval for the XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent Systems (XIENCE Sierra EECSS), and the XIENCE Skypoint Everolimus Eluting Coronary Stent System (XIENCE Skypoint EECSS).The XIENCE [Alpine / Sierra / Skypoint] stent system is indicated for improving coronary artery luminal diameter in patients, including those at high risk for bleeding and those with diabetes mellitus, with symptomatic heart disease due
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NC TREK NEO Coronary Dilatation Catheter (K220634) | Abbott Vascular | 2022-06-30 |
| Viatrac 14 Plus Peripheral Dilatation Catheter (K221057) | Abbott Vascular | 2022-05-05 |
| HI-TORQUE PROCEED Guide Wire Family (K201834) | Abbott Vascular | 2020-07-30 |
| HI-TORQUE Steelcore Bare Guide Wire (K200144) | Abbott Vascular | 2020-04-08 |
| HI-TORQUE InfilTrac Guide Wire Family (K193126) | Abbott Vascular | 2019-12-11 |
| Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (K191173) | Abbott Vascular | 2019-07-25 |
| NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter (K180040) | Abbott Vascular | 2018-08-24 |
| HI-TORQUE TurnTrac Guide Wire Family (K173795) | Abbott Vascular | 2018-01-12 |