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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.
 
DevicePERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM
ApplicantABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City, CA 94063
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/Material
Expedited Review Granted? No
Combination ProductNo
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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