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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 ProGlide® Suture-Mediated Closure System, Prostar® XL Percutaneous Vascular Surgical System
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS124
Date Received09/06/2024
Decision Date02/10/2025
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 Centerpiece S. de. R.L. de C.V., Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada 11530, Tijuana, Baja California, 22250, Mexico for sterilization.
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