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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.
 
DeviceCELT ACD Vascular Closure Device
Generic NameDevice, hemostasis, vascular
ApplicantVasorum, Ltd.
2012 Orchard Ave.
Citywest Business Campus
Dublin 24
PMA NumberP150006
Supplement NumberS007
Date Received12/05/2025
Decision Date12/18/2025
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  
a new adhesive to be used in the Tyvek packaging lid
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