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 RX CAROTID STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P060001 |
Supplement Number | S017 |
Date Received | 08/21/2012 |
Decision Date | 02/12/2013 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE CREATE POST- APPROVAL STUDY (PAS) RESULTS TO THE INSTRUCTIONS FOR USE (IFU). |
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