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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.
 
DeviceProstar™ XL Percutaneous Vascular Surgical System, Perclose ProGlide™ Suture-Mediated Closure System, Perclose™ ProStyle
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS119
Date Received11/16/2022
Decision Date12/16/2022
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Implementation of a sustainable ethylene oxide (SEO) sterilization cycle ("soft" cycle) at the Synergy Health Ireland facility.
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