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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 NameCLOSER S(TM) 6FR. SMC DEVICE
Generic Namefemoral artery closure system
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS026
Date Received08/31/2000
Decision Date09/29/2000
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the closer s(tm) 6 fr. Suture mediated closure (smc) system. The device, as modified, is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic catheterization procedures using 5 to 6 fr. Sheaths. The closer s(tm) 6 fr. Suture mediated closure (smc) system reduces the times to hemostasis, ambulation (5 meters or 16 feet) and discharge in patients who have undergone diagnostic catheterization procedures without complicating clinical conditions (refer to precautions, special patient populations in the device labeling).
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