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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 supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS001
Date Received05/08/2008
Decision Date07/02/2008
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the sheath. The device, as modified, will be marketed under the trade name fish-sp and is indicated 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, and 8 french procedural sheaths.
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