INTRASTENT DOUBLESTRUT STENT
FDA premarket approval P030045/S002 · decided 2015-04-16
Approval details
- PMA number
- P030045
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTRASTENT DOUBLESTRUT STENT
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2013-10-30
- Decision date
- 2015-04-16
- Days to decision
- 533 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A DESIGN MODIFICATION TO THE INTRASTENT DOUBLESTRUT STENT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISI-PRO BALLOON-EXPANDABLE PERIPHERAL STENT SYSTEM AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITHA REFERENCE VESSEL DIAMETER OF 5 TO 10 MM.
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510(k) clearances by this applicant
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|---|---|---|
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
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| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |