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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.
 
DeviceCORDIS EXOSEAL VASCULAR CLOSURE DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP100013
Supplement NumberS021
Date Received09/10/2021
Decision Date09/28/2021
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change to the degreasing solution and system used in the manufacturing of the indicator wire component of the EXOSEAL Vascular Closure Device.
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