|
Device | POWERLINK SYSTEM VISIFLEX IS DELIVERY CATHETERS |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 2 Musick Irvine, CA 92618 |
PMA Number | P040002 |
Supplement Number | S017 |
Date Received | 04/11/2008 |
Decision Date | 06/12/2008 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE NEW VISIFLEX IS BIFURCATED AND STRAIGHT DELIVERY CATHETERS. |
Post-Approval Study | Show Report Schedule and Study Progress |