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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 Dr.
Danvers, MA 01923
PMA NumberP040022
Supplement NumberS002
Date Received07/17/2006
Decision Date11/01/2006
Withdrawal Date10/12/2010
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 STD MED, INC., STOUGHTON, MASSACHUSETTS.
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