INTRASTENT DOUBLESTRUT STENT
FDA premarket approval P030045 · decided 2004-06-08
Approval details
- PMA number
- P030045
- Trade name
- INTRASTENT DOUBLESTRUT STENT
- Generic name
- STENT, ILIAC
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2003-09-30
- Decision date
- 2004-06-08
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE INTRASTENT DOUBLESTRUT STENT. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 10 MM.
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