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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 6 FR. SUTURE MEDICATED CLOSURE (SMC) SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS042
Date Received10/08/2002
Decision Date11/12/2002
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanding the indications for use of the closer a-t 6 fr. Smc system to include 7 and 8 fr. Sheath sizes and to change the labeling to include <0. 038" guidewires.
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