Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceGORE EXCLUDER AAA ENDOPROSTHESIS
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. Gore & Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP020004
Supplement NumberS039
Date Received11/03/2008
Decision Date03/05/2009
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE 31 MM GORE EXCLUDERENDOPROSTHESIS. THE 31 MM GORE EXCLUDERS ENDOPROSTHESIS INCLUDES TWO COMPONENTSTHAT WERE NOT INCLUDED IN PRIOR SUBMISSIONS: THE 31 MM TRUNK-IPSILATERAL LEG AND THE 32MM AORTIC EXTENDER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GOREEXCLUDERS AAA ENDOPROSTHESIS AND IS INTENDED TO EXCLUDE THE ANEURYSM FROM BLOODCIRCULATION IN PATIENTS WHO HAVE APPROPRIATE ANATOMY AS FOLLOWS:1) ADEQUATE ILIAC/FEMORAL ACCESS;2) INFRARENAL AORTIC NECK TREATMENT DIAMETER RANGE OF 19-29 MM AND A MINIMUM AORTICNECK LENGTH OF 15 MM; 3) PROXIMAL AORTIC NECK ANGULATION LESS THAN OR EQUAL TO 60 DEGREES; AND 4) ILIAC ARTERY TREATMENT DIAMETER RANGE OF 8-18.5 MM AND ILIAC DISTAL VESSEL SEAL ZONE LENGTH OF AT LEAST 10 MM.
-
-