Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: ANCURE(TM) ENDOGRAFT(R) SYSTEM
• Applicant: Boston Scientific Corp; 4100 Hamline Ave. N; 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for labeling changes under 21 CFR 814.39(d)