XACT CAROTID STENT SYSTEM
FDA premarket approval P040038 · decided 2005-09-06
Approval details
- PMA number
- P040038
- Trade name
- XACT CAROTID STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2004-09-03
- Decision date
- 2005-09-06
- Days to decision
- 368 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE XACT CAROTID STENT SYSTEM. THE XACT CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH THE ABBOTT VASCULAR DEVICES EMBOLIC PROTECTION SYSTEM, IS INDICATED FOR THE IMPROVEMENT OF THE LUMEN DIAMETER OF CAROTID ARTERIES IN PATIENTS CONSIDERED AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY WHO REQUIRE PERCUTANEOUS CAROTID ANGIOPLASTY AND STENTING FOR OCCLUSIVE ARTERY DISEASE AND MEET THE CRITERIA OUTLINED AS FOLLOWS: 1) PATIENTS WITH CAROTID ARTERY STENOSIS (>= 50% FOR SYMP
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
| PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067) | Abbott Vascular, Inc. | 2013-01-29 |
| HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573) | Abbott Vascular, Inc. | 2012-11-20 |
| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (K101011) | Abbott Vascular, Inc. | 2010-05-24 |
| HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825) | Abbott Vascular, Inc. | 2009-09-25 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |