Xience Skypoint Everolimus Eluting Coronary Stent System
FDA premarket approval P110019 · decided 2011-11-01
Approval details
- PMA number
- P110019
- Trade name
- Xience Skypoint Everolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2011-04-20
- Decision date
- 2011-11-01
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 32 MM) WITH REFERENCE VESSEL DIAMETERS OF >= 2.25 MM TO <= 4.25 MM.
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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 |