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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 MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS044
Date Received03/03/2003
Decision Date04/04/2003
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to: replace the brained suture with a monofilament polypropylene suture; combine the instructions for use of the perclose a-t monofilament 6 fr. Suture mediated closure (smc) system and the chito-seal device into a single pamphlet. The device, as modified, will be marketed under the trade name perclose a-t monofilament 6 fr. Suture mediated closure (smc) system and is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic and interventional catheterization procedures using 5 to 8 fr. Sheaths. The perclose a-t monofilament 6 fr. Smc system reduces the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic and interventional catheterization procedures without complicating clinical conditions.
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