|
Device | ZENITH TX2 THORACIC ENDOVASCULAR GRAFT |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | WILLIAM COOK EUROPE APS SANDET 6, DK-4632 BJAEVERSKOV |
PMA Number | P070016 |
Supplement Number | S007 |
Date Received | 04/23/2013 |
Decision Date | 05/20/2013 |
Withdrawal Date
|
02/24/2020 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATING SEVERAL SECTIONS IN THE IFU REGARDING MAINTAINING HEMOSTASIS, TRIGGER WIRE RELEASE, AND MRI SAFETY INFORMATION. |