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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 NameTHE PERCLOSE A-T (AUTO TIE) SMC DEVICE
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS041
Date Received07/26/2002
Decision Date08/21/2002
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a device name change, company name change, and labeling changes. The device, as modified, will be marketed under the trade name perclose a-t (auto tie) suture mediated closure (smc) device and is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 6 fr. Sheaths. The perclose a-t 6 fr. Smc systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions.
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