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 | AFX ENDOVASCULAR AAA SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 2 Musick Irvine, CA 92618 |
PMA Number | P040002 |
Supplement Number | S041 |
Date Received | 05/02/2013 |
Decision Date | 06/17/2013 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A RELEASE SLEEVE TO THE PROXIMAL EXTENSION ACCESSORY STENT GRAFT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX VELA PROXIMAL ENDOGRAFT SYSTEM. |
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