| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | INTRA COIL SELF-EXPANDING PERIPHERAL STENT |
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| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
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| Applicant | Medtronic Vascular, Inc.
3033 Campus Dr.
Maple Grove, MN 55441 |
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| PMA Number | P000033 |
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| Date Received | 08/03/2000 |
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| Decision Date | 04/03/2002 |
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| Withdrawal Date | 03/30/2018 |
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| Product Code |
NIP |
| Docket Number | 02M-0235 |
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| Notice Date | 05/24/2002 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE INTRACOIL SELF-EXPANDING PERIPHERAL STENT. THIS DEVICE IS INDICATED FOR IMPROVING PERIPHERAL LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC DISEASE DUE TO STENOTIC LESIONS (LENGTH <= 15 CM) OR OCCLUSIVE LESIONS (LENGTH <= 12 CM) IN FEMOROPOPLITEAL ARTERIES, TO THE BIFURCATION OF THE TIBIAL ARTERY, WITH A REFERENCE VESSEL DIAMETER OF 3.0 TO 7.8 MM. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 |
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