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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 NameX-SITE SUTURE-MEDIATED CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP020035
Supplement NumberS002
Date Received12/15/2005
Decision Date03/03/2006
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for various labeling changes and ergonomic changes to the device. The device, as modified, will be marketed under the trade name x-site suture-mediated closure 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 coronary catheterization procedures using sheaths less than or equal to 6 fr. The x-site suture-mediated closure device is intended to reduce the time to h0mostasis, time to ambulation (100 feet), and time to dischargeability in patients who have undergone diagnostic or interventional coronary catheterization procedures without complicating clinical conditions, including those receiving glycoprotein iib/iiia inhibitors. ?.
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