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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.
 
DeviceVASOSEAL 4-5 FRENCH SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
St. Jude Medical, Inc.
177 e.county rd. b east
st paul, MN 55117
PMA NumberP920004
Supplement NumberS017
Date Received02/14/2002
Decision Date06/11/2002
Product Code
MGB[ Registered Establishments with MGB ]
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 TO MARKET A SMALLER VERSION OF THE VASOSEAL VHD DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VASOSEAL 4-5 FRENCH SYSTEM AND IS INDICATED FOR "USE IN SEALING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES USING A 4 OR 5 FRENCH PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL 4-5 FRENCH SYSTEM REDUCES TIME TO HEMOSTASIS, AMBULATION AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES."
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