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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.
 
Device7F FISH-SP DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantMORRIS INNOVATIVE RESEARCH INC
907 W.SECOND ST
BLOOMINGTON, IN 47403
PMA NumberP050043
Supplement NumberS002
Date Received05/26/2009
Decision Date07/24/2009
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE 7F FISH-SP DEVICE TO THE FISH PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 7F FISH-SP DEVICE FOR CLOSURE AND IS INDICATED FOR PERCUTANEOUS ACCESS AND CLOSURE OF THE COMMON FEMORAL ARTERY WHILE REDUCING TIME TO HEMOSTASIS, AMBULATION AND TIME TO ELIGIBLE DISCHARGE IN PATIENTS REQUIRING ACCESS OF 7F FOR ENDOVASCULAR PROCEDURE WITH SHEATH REMOVAL.
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