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 | S043 |
Date Received | 07/12/2013 |
Decision Date | 08/12/2013 |
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 OF NEW PLATINUM/TUNGSTEN RADIOPAQUE COIL MARKERS TO BE ADDED CIRCUMFERENTIALLY IN THE PROXIMAL HEM OF THE SUPRARENAL AND INFRARENAL PROXIMAL EXTENSION ACCESSORY STENT GRAFTS. |
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