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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 NamePERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS005
Date Received03/09/1998
Decision Date09/02/1998
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified percutaneous vascular surgical (pvs) system. The device, as modified, will be marketed under the trade name prostar(r) xl 10 french percutaneous vascular surgical (pvs) system and is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8. 5f to 10f sheaths.
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