ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
FDA premarket approval P110028 · decided 2012-02-22
Approval details
- PMA number
- P110028
- Trade name
- ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2011-07-25
- Decision date
- 2012-02-22
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESIONS IN THE NATIVE COMMON ILIAC ARTERY AND NATIVE EXTERNAL ILIAC ARTERY WITH REFERENCE VESSEL DIAMETERS BETWEEN 4.3 MM AND 9.1 MM AND LESIONS LENGTHS UP TO 90 MM.
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 |
|---|---|---|
| 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 |