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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 AND HEMOSTASIS DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantMorris Innovative Research, Inc.
907 W. Second St.
Bloomington, IN 47403
PMA NumberP050043
Supplement NumberS006
Date Received01/13/2012
Decision Date02/28/2012
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 A NEW VERSION OF THE SUB-INTESTINAL SUBMUCOSA (SIS) MATERIAL (VERSION 2.0).
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