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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.
 
DeviceCLOSER VASCULAR SEALING SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantRex Medical, L.P.
555 E. N. Ln.
Suite 5035
Conshohocken, PA 19428
PMA NumberP150022
Supplement NumberS002
Date Received08/15/2016
Decision Date11/10/2016
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 to implement minor design modifications to the production sheath cap.
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