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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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. North Valley Parkway
Phoenix, AZ 85085
PMA NumberP020004
Supplement NumberS023
Date Received05/21/2007
Decision Date06/26/2007
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE TO EMPHASIZE THE APPROPRIATE WITHDRAWAL PROCEDURES FOR THE DELIVERY CATHETER AND SHEATH IF RESISTANCE IS FELT DURING REMOVAL. THESE CHANGES INCLUDED MODIFICATIONS TO THE DIRECTIONS FOR USE AS WELL AS THE ADDITION OF A WARNING/ PRECAUTION REGARDING THE POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH FORCIBLY WITHDRAWING THE DELIVERY CATHETER THROUGH THE INTRODUCER SHEATH.
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