|
Device | ANCURE(TM) ENDOGRAFT(R) SYSTEM |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P990017 |
Supplement Number | S004 |
Date Received | 12/14/1999 |
Decision Date | 01/07/2000 |
Withdrawal Date
|
09/19/2011 |
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 labeling changes under 21 CFR 814.39(d) |