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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
Generic NameDevice, hemostasis, vascular
ApplicantSt. Jude Medical, Inc.
177 E. County Rd. B E.
St Paul, MN 55117
PMA NumberP920004
Supplement NumberS017
Date Received02/14/2002
Decision Date06/11/2002
Withdrawal Date12/06/2013
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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