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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 DEVICE (FISH)
Classification Namedevice, hemostasis, vascular
ApplicantMORRIS INNOVATIVE RESEARCH INC
PMA NumberP050043
Supplement NumberS004
Date Received01/18/2011
Decision Date03/17/2011
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: 1) replacing the sewn two-piece small intestine submocosa (sis) assembly with a single sis piece; 2) decreasing the sis cuff length and ribbon width; 3) modifying the sis patch to release wire connection; and 4) changing the sheath material from a high density polyethylene (hdpe) to fluorinated ethylene propylene (fep).
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