Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: GORE HELEX SEPTAL OCCLUDER
• Generic Name: Transcatheter septal occluder
• Applicant: W.L. GORE & ASSOCIATES,INC; 32360 N NORTH VALLEY PARKWAY; PHOENIX, AZ 85085-1505
• PMA Number: P050006
• Date Received: 03/01/2005
• Decision Date: 08/11/2006
• Product Code: MLV
• Docket Number: 06M-0341
• Notice Date: 08/25/2006
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE GORE HELEX SEPTAL OCCLUDER. THE DEVICE IS A PERMANENTLY IMPLANTED PROSTHESIS INDICATED FOR THE PERCUTANEOUS, TRANSCATHETER CLOSER OF OSTIUM SECUNDUM ATRIAL SEPTAL DEFECTS (ASDS).

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 ; S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 ; S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 ; S048 S049 S050 S051 S052 S053 S054 S055 S056 S058 S059 S060 ; S061 S062 S063 S064 S065 S067 S068 S069 S070 S071 S072 S073 ; S074 S075 S076 S077 S078 S080 S081 S082 S083 S084 S085 S086 ; S087 S088 S089 S091 S092 S093 S094 S095 S096 S097 S098 S099 ; S100 S101 S102 S104 S105 S106 S107 S108 S110