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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
St. 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
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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.