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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, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator
Generic NameDevice, hemostasis, vascular
ApplicantTeleflex Medical, LLC
3015 Carrington Mill Blvd.
Morrisville, NC 27560
PMA NumberP180025
Supplement NumberS010
Date Received01/13/2023
Decision Date10/11/2023
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional manufacturing site in Tecate, Mexico and an additional sterilization site (Sterigenics West Memphis, AR facility) for the subject device.
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