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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 NumberS004
Date Received09/07/2016
Decision Date10/21/2016
Product Code PJQ 
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 alternate site located at Medtronic, Ireland, Parkmore Business Park, West Galway, Ireland, to perform finished device final release activities.
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