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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameFEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
Classification Namedevice, hemostasis, vascular
ApplicantMORRIS INNOVATIVE RESEARCH INC
PMA NumberP050043
Date Received11/23/2005
Decision Date08/20/2007
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 07M-0344
Notice Date 09/18/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the femoral introducer sheath and hemostasis (fish) device 5, 6, and 8 french. The device is indicated as follows: the femoral introducer sheath and hemostasis (fish) device is intended for hemostatic closure of femoral artery access sites. The system is indicated for use in reducing time to hemostasis and time to ambulation in patients who have undergone diagnostic procedures using 5, 6, or 8 french procedural sheaths.
Approval Order Approval Order
Supplements: S001 S002 S004 S005 S006 
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