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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 AK 6 FR. SMC DEVICE
Classification Namedevice, hemostasis, vascular
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS039
Date Received04/17/2002
Decision Date05/21/2002
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 manufacturing and material design changes, i. E. , changing to a press-fit handle, to a green and white suture, to an internal suture storage, changing the thumb cap/plunger attachment back to what was previously approved in p960043/s036, and a change in the o-ring material. In addition, the labeling is being modified to include other healthcare professionals in the precaution on the limitation of use to physicians who have been trained in the use of this device. The device, as modified, will be marketed under the trade name closer ak 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 or interventional catheterization procedures using 5 to 6 fr. Sheaths. The closer 6 fr. Smc systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic and interventional catheterization procedures without complicating clinical conditions (refer to precautions, special patient populations).
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