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 | COMPLETE SE VASCULAR STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P090006 |
Supplement Number | S007 |
Date Received | 08/08/2011 |
Decision Date | 09/07/2011 |
Withdrawal Date
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05/23/2019 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00730730
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Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REDUCTION IN PYROGEN TESTING SAMPLE SIZE. |
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