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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 Closure System
Generic NameDevice, hemostasis, vascular
ApplicantABBOTT VASCULAR DEVICES
3200 LAKESIDE DRIVE
SANTA CLARA, CA 95054
PMA NumberP050007
Supplement NumberS041
Date Received05/18/2021
Decision Date06/15/2021
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Increase the maximum pressure for the Clip Applier wire control machine that is used during the wire controller assembly process for StarClose SE® Vascular Closure System
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