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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.
 
DevicePerclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System
Generic NameDevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City, CA 94063
PMA NumberP960043
Supplement NumberS118
Date Received09/19/2022
Decision Date06/02/2023
Product Code MGB 
Docket Number 23M-2708
Notice Date 07/07/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT03546439
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Perclose ProStyle Suture-Mediated Closure and Repair System and Perclose ProGlide Suture-Mediated Closure System for closure of multiple access sites in a single femoral vein.The Perclose ProGlide Suture-Mediated Closure System/Perclose ProStyle Suture-Mediated Closure and Repair System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures. The Perclose ProGlide SMC System/Perclose ProStyle SMCR System is indicated for closing the common femoral vein in single or multiple access sites per limb. The Perclose ProGlide SMC System/Perclose ProStyle SMCR System is used without or, if required, with adjunctive manual compression. For access sites in the common femoral artery using 5F to 21F sheaths. For arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required. For access sites in the common femoral vein using 5F to 24F sheaths. For venous sheath sizes greater than 14F, at least two devices and the pre-close technique are required.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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