|
Device | ANCURE ENDOGRAFT 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 | S008 |
Date Received | 08/16/2000 |
Decision Date | 10/16/2000 |
Withdrawal Date
|
09/19/2011 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ENHANCEMENTS TO THE MANUFACTURING PROCESS FOR THE ANCURE SYSTEM |