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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePERCLOSE AT 6 FRENCH SUTURE MEDIATED CLOSER (SMC) SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS049
Date Received10/27/2003
Decision Date11/25/2003
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the instructions for use. These changes strengthen the procedural instructions for using the device and add a precaution to not use excessive force or torque to advance the device, stating that such actions may result in: "ignificant arterial damage and/or breakage of the device, which may necessitate surgical removal of the device and arterial repair. " in addition to these labeling changes, you have also indicated that the physician training protocol has been revised to further address this concern.
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