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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 NameCLOSER 6 FR. SUTURE MEDIATED CLOSURE DEVICE
Generic Namefemoral artery closure system
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS024
Date Received04/04/2000
Decision Date05/19/2000
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the marker tube of the closer(tm) smc device.
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