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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVASCULAR SOLUTIONS DUETT SEALING DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantVASCULAR SOLUTIONS, INC.
PMA NumberP990037
Date Received06/30/1999
Decision Date06/22/2000
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 00M-1390
Notice Date 07/12/2000
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the vascular solutions duett(tm) sealing device. This device is indicated for sealing femoral arterial puncture sites and reducing time to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a 5f-9f introducer sheath with an overall length not exceeding 15. 2 cm.
Approval Order Approval Order
Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S018 S019 S020 S021 
S022 S023 S024 S025 S026 S028 S029 S030 S031 
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