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: Angio Seal Vascular Closure Device
• Generic Name: Device, hemostasis, vascular
• Applicant: TERUMO MEDICAL CORPORATION; 950 ELKTON BLVD.; ELKTON, MD 21921
• PMA Number: P930038
• Date Received: 10/28/1993
• Decision Date: 09/30/1996
• Product Code: MGB
• Docket Number: 97M-0259
• Notice Date: 07/10/1997
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE

• Supplements: S001 S002 S076 S065 S019 S020 S021 S022 S023 S024 S028 ; S029 S030 S031 S082 S040 S041 S069 S050 S061 S014 S015 S016 ; S017 S032 S038 S039 S004 S005 S006 S007 S009 S010 S011 S012 ; S013 S055 S051 S036 S046 S044 S045 S025 S026 S027 S018 S066 ; S067 S068 S075 S072 S071 S074 S077 S078 S070 S034 S035 S047 ; S052 S054 S048 S063 S033 S042 S043 S060 S064 S049 S057 S058 ; S062 S079 S080 S081 S084 S083 S085 S095 S096 S094 S090 S098 ; S089 S087 S088 S086 S091 S092 S093 S097 S100 S099 S101