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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 NumberS003
Date Received03/08/2007
Decision Date05/24/2007
Withdrawal Date10/12/2010
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR INCORPORATION OF THE FOLLOWING PROCESSING AND MATERIAL CHANGES TO THE DISTAL END OF THE VCS 1000 DILATOR: 1) CHANGE IN THE DILATOR MATERIAL FROM NYLON 11 TO PEBAX NYLON 4033 FOR THE DILATOR DISTAL TIP AND FROM NYLON 11 TO PEBAX NYLON 6033 FOR THE DILATOR DISTAL SHAFT; 2) ADDITION OF A RF AND/OR ALTERNATIVE THERMAL ENERGY SOURCE TO BOND THE DILATOR DISTAL TIP TO THE DISTAL SHAFT; AND 3) ADDITION OF A HEAT SHRINK SLEEVE TO ENHANCE THE BOND BETWEEN THE SHAFT AND THE DISTAL TIP.
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