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 |
PMA Number | P180010 |
Supplement Number | S003 |
Date Received | 02/04/2019 |
Decision Date | 03/06/2019 |
Withdrawal Date
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05/20/2019 |
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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