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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.
 
DeviceANGIOLINK VASCULAR CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantMedtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923
PMA NumberP040022
Supplement NumberS001
Date Received05/15/2006
Decision Date10/02/2006
Withdrawal Date 10/12/2010
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR VARIOUS MANUFACTURING PROCESS CHANGES TO ENSURE CONSISTENCY.
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