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 | GORE Carotid Stent |
Generic Name | stent, carotid |
Applicant |
W. L Gore & Associates, Inc |
4250 w. kiltie lane |
flagship, AZ 86005 |
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PMA Number | P180010 |
Supplement Number | S003 |
Date Received | 02/04/2019 |
Decision Date | 03/06/2019 |
Product Code |
NIM
|
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product |
Yes
|
Approval Order Statement
Update raw material specifications and non-compendial test methods. |
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