|
Device | ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEMS |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P990017 |
Supplement Number | S012 |
Date Received | 11/06/2000 |
Decision Date | 02/15/2001 |
Withdrawal Date
|
09/19/2011 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE TRAINING PROGRAM TO ALLOW LESS THAN 100% CASE SUPPORT AT CENTERS THAT MEET THE ESTABLISHED CRITERIA. THIS CHANGE AFFECTS THE CONDITIONS OF APPROVAL DESCRIBED IN THE ORIGINAL APPROVAL ORDER, DATED SUPTEMBER 28, 1999. |