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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 NumberS011
Date Received02/06/2024
Decision Date03/06/2024
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  
to add an additional sterilization irradiator for the Manta VCD Product Family
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