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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 NumberS024
Date Received03/17/2021
Decision Date06/15/2021
Product Code PJQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a T=12 and 30 month shelf-life specification for the Stabilizer A component of greater than or equal to 175 ug/g for the VenaSeal Adhesive.
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