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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 NameDIAGNOSTIC DUETT
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantVASCULAR SOLUTIONS, INC.
PMA NumberP990037
Supplement NumberS001
Date Received10/04/2000
Decision Date11/02/2001
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the change in diluent and procoagulant components. The device, as modified, will be marketed under the trade name diagnostic duett and 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.
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