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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.
 
DevicePROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL
ApplicantABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City, CA 94063
PMA NumberP960043
Supplement NumberS002
Date Received06/02/1997
Decision Date12/29/1997
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 modified Percutaneous Vascular Surgical (PVS) Systems. The devices, as modified, will be marketed under the trade names Prostar(R) Plus 8 French, Prostar(R) Plus 10 French, and Prostar(R) XL 8 French PVS Systems. The Prostar(R) Plus and Prostar(R) XL PVS Systems consist of a PVS Device and a Perclose(R) Knot Pusher. The Prostar(R) Plus and Prostart(R) XL PVS Systems are indicated for the percutaneous deliveyr of sutures for closing the common femoral artery access site and reducing hte time to hemostasis and ambulation (patient walks ten feet) of patients who have undegone catheterization procedures using 6.5 French to 10 French sheaths.
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