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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 NumberS007
Date Received04/15/1998
Decision Date05/05/1999
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional effectiveness claim (i.e., reduced time to discharge) for the Prostar(R) XL 8F Percutaneous Vascular Surgical (PVS) System. The device will be marketed under the trade name Prostar(R) XL 8F Percutaneous Vascular Surgical (PVS) System and is now indicated for: "the percutaneous delivery of sutures for closing the common femoral artery access site and reducing time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 6.5 Fr. to 8 Fr. sheaths. The Prostar XL 8 Fr. System reduces the time to discharge in patients having undergone diagnostic catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations)."