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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 ES AND VHD DEVICES
Generic NameDevice, hemostasis, vascular
ApplicantSt. Jude Medical, Inc.
177 E.COUNTY RD. B EAST
ST PAUL, MN 55117
PMA NumberP920004
Supplement NumberS015
Date Received03/12/2001
Decision Date09/20/2001
Withdrawal Date 12/06/2013
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO MODIFY LANGUAGE IN THE INSTRUCTIONS FOR USE (IFU) FOR THE VASOSEAL EA AND VASOSEAL VHD DEVICES TO ADD CLINICAL STUDY DATA TO THE LABELING FOR BOTH DEVICES IN SUPPORT OF A NEW CLAIM FOR REDUCED TIME-TO-DISCHARGE FOR DIAGNOSTIC ANGIOGRAPHY PATIENTS AND TO EXPAND THE INDICATIONS FOR USE FOR THE VASOSEAL VHD DEVICE FROM BALLOON ANGIOPLASTY OR STENT PROCEDURES TO THE GENERAL CATEGORY OF INTERVENTIONAL PROCEDURES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES VASOSEAL ES AND VASOSEAL VHD AND THE VASSEAL VHD IS INDICATED FOR USE IN SEALING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND RETROGRADE APPROACH. THE VASOSEAL VHD REDUCES TIME TO HEMOSTASIS, AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES. IN ADDITION, THE VASOSEAL VHD REDUCES TIME TO DISCHARGE IN DIAGNOSTIC PATIENTS. THE VASOSEAL VHD ALSO REDUCES TIME TO HEMOSTASIS IN INTERVENTIONAL PATIENTS, WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED. HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DEMONSTRATED.
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