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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.
 
DeviceStarClose SE® Vascular Surgical System
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular Devices
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP050007
Supplement NumberS047
Date Received05/12/2025
Decision Date12/09/2025
Product Code MGB 
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 a manufacturing site located at Synergy Health AST, SRL, B13.1 Street 4, Avenue 1, Coyol Free Zone, Coyol, Alajuela, 20102, Costa Rica for sterilization.
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