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 | POWERLINK SYSTEMWITH INTUITRAK DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 2 Musick Irvine, CA 92618 |
PMA Number | P040002 |
Supplement Number | S027 |
Date Received | 03/25/2010 |
Decision Date | 05/12/2010 |
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 NEW POWERLINK SYSTEM MODELS, INCLUDING BIFURCATED DEVICES WITH NEW LENGTHS AND DIAMETERS, LIMB EXTENSIONS WITH NEW LENGTHS, AND AORTIC EXTENSIONS WITH NEW LENGTHS. |
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