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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 PLUS Vascular Closure Device
Generic NameDevice, hemostasis, vascular
ApplicantVasorum, Ltd.
2012 Orchard Ave.
Citywest Business Campus
Dublin 24
PMA NumberP150006
Supplement NumberS006
Date Received10/23/2024
Decision Date01/24/2025
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 for a CELT ACD PLUS device which included a blood signal indicator
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