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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 & HEMOSTASIS (FISH) DEVICE
Classification Namedevice, hemostasis, vascular
ApplicantMORRIS INNOVATIVE RESEARCH INC
PMA NumberP050043
Supplement NumberS005
Date Received05/12/2011
Decision Date07/11/2011
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: adding a cuff stabilizer sheath, modifying the suture indicator knots and updating labeling. The device, as modified, will be marketed under the trade name fish- sp advanced compression device and is indicated for ". 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, 7 or 8 french procedural sheaths. ".
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