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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePERCLOSE A-T 6 FR. SUTURE MEDICATED CLOSURE (SMC) SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR INC.
400 saginaw drive
redwood city, CA 94063
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/instructions/shelf life/tradename
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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