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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 Dr.
Plymouth, MN 55441
PMA NumberP140018
Supplement NumberS037
Date Received05/01/2023
Decision Date07/25/2023
Product Code PJQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for removing the guidewire included in the VenaSeal Closure system and instructing physicians to source a compatible guidewire for the procedure.
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