|
Device | POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Endologix, LLC 2 Musick Irvine, CA 92618 |
PMA Number | P040002 |
Supplement Number | S010 |
Date Received | 03/15/2007 |
Decision Date | 04/04/2007 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO THE FRONT SHEATH SUBASSEMBLY OF THE VISIFLEX DELIVERY SYSTEM. |
Post-Approval Study | Show Report Schedule and Study Progress |