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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.
 
DevicePERCLOSE A-T AND PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE (SMC) SYSTEMS
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR INC.
400 saginaw drive
redwood city, CA 94063
PMA NumberP960043
Supplement NumberS054
Date Received07/02/2004
Decision Date07/15/2004
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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