|
Device | ANCURE SYSTEM |
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 | S038 |
Date Received | 02/10/2003 |
Decision Date | 08/08/2003 |
Withdrawal Date
|
09/19/2011 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FORMAT TO BE USED FOR THE CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIANS USERS AT LEAST ANNUALLY. THE INFORMATION CONTAINED IN THIS UPDATE WILL BE PROVIDED TO THE FDA VIA THE PMA ANNUAL REPORT. |