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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.
 
DeviceVenaseal Closure System
Generic NameAgent, occluding, vascular, permanent
ApplicantMEDTRONIC VASCULAR INC
3033 Campus Drive
Plymouth, MN 55441
PMA NumberP140018
Supplement NumberS025
Date Received04/23/2021
Decision Date05/21/2021
Product Code PJQ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for additional verification of the date of manufacture and use by date for devices undergoing rework activities.
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