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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 Dr.
Santa Clara, CA 95054
PMA NumberP050007
Supplement NumberS038
Date Received04/24/2019
Decision Date05/23/2019
Product Code MGB 
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  
Manufacturing move within an approved facility for the Prostar XL Percutaneous Vascular Surgical System and the StarClose SE Vascular Closure System.
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