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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 NumberS004
Date Received01/08/2018
Decision Date02/07/2018
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to modify the magnetic resonance imaging safety labeling.
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