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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.
 
DeviceMANTA™ Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L
Generic NameDevice, hemostasis, vascular
ApplicantTeleflex Medical, LLC
3015 Carrington Mill Blvd.
Morrisville, NC 27560
PMA NumberP180025
Supplement NumberS014
Date Received07/10/2025
Decision Date08/05/2025
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 change to conduct the final release testing of the Manta VCD product family in a new location within the same facility
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