XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA premarket approval P110019/S062 · decided 2014-09-04
Approval details
- PMA number
- P110019
- Supplement
- S062
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
- Generic name
- Coronary drug-eluting stent
- Applicant
- Abbott Vascular
- Date received
- 2014-01-30
- Decision date
- 2014-09-04
- Days to decision
- 217 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE POST APPROVAL STUDY LABELING UPDATES FOR THE CLINICAL STUDIES FOLLOWED UNDER THIS PMA FOR THE XIENCE PRIME AND XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |