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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 A-T AND PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE (SMC) SYSTEMS
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR DEVICES
PMA NumberP960043
Supplement NumberS054
Date Received07/07/2004
Decision Date07/15/2004
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modified sheath and foot assemblies on the perclose a-t and proglide devices and the addition of a suture cutter on the perclose a-t device.
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