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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
400 saginaw drive
redwood city, CA 94063
PMA NumberP960043
Supplement NumberS019
Date Received05/03/1999
Decision Date11/22/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Closer(TM) PVS Device and the following accessories: the Perclose Mini Knot Pusher, Perclose Snared Knot Pusher and the Clincher(TM) Knot Tying Device. The device is indicated for the percutaneous delivery of suture for closing hte common femoral artery access sie of patients who have undergone diagnostic catheterization procedures using 5 to 6 Fr. sheaths. The Closer(TM) 6 Fr. PVS System reduces the times to hemostasis, ambulation (5 meters or 16 feet) and discharge in patients who have undergone diagnostic catherization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations in the device labeling).