| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | PROTEGE GPS SELF EXPANDING PERIPHERAL STENT SYSTEM |
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| Generic Name | Stent, carotid |
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| Applicant | Medtronic Vascular, Inc.
3033 Campus Dr.
Plymouth, MN 55441 |
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| PMA Number | P060001 |
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| Supplement Number | S020 |
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| Date Received | 05/02/2014 |
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| Decision Date | 01/21/2015 |
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| Product Codes |
NIM NIO |
| Docket Number | 15M-0228 |
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| Notice Date | 01/23/2015 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT01400919
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR THE PROTÉGÉ GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO AND INCLUDING 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF7.5 TO 11 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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