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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.
 
Trade NameVASOSEAL 4-5 FRENCH SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantDATASCOPE CORP.
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 - other
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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