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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)
Generic NameDevice, hemostasis, vascular
ApplicantMorris Innovative Research, Inc.
907 W. Second St.
Bloomington, IN 47403
PMA NumberP050043
Supplement NumberS004
Date Received01/18/2011
Decision Date03/17/2011
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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