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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 CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS035
Date Received11/19/2001
Decision Date12/28/2001
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification of the closer s suture-mediated closure (smc) device to allow for a pre-tied knot upon device use. The device, as modified, will be marketed under the trade name closer ii 6fr. 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 6 fr. Sheaths. The closer ii 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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