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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 NameVASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantVASCULAR SOLUTIONS, INC.
PMA NumberP990037
Supplement NumberS024
Date Received06/28/2006
Decision Date12/22/2006
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 07M-0188
Notice Date 05/11/2007
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for a new indication for use for the d-stat flowable hemostat. The device is indicated for use in high-risk anti-coagulated patients undergoing implantation of a pulse generator (e. G. , pacemaker or icd) to reduce the frequency of clinically relevant hematoma formation in the prepectoral pocket. D-stat flowable is indicated for use in high-risk anti-coagulated patients undergoing implantation of a pulse generator (e. G. , pacemaker or icd to reduce the frequency of clinically relevant hematoma formation in the prepectoral pocket. High-risk patients are defined as those whose anti-coagulation regimens will resume within 24 hours of implant. Clinically relevant hematomas are defined as those that result in an alteration in the standard of care resultant of hematoma formation including alteration (i. E. Suspension or discontinuation) of the anticoagulant therapy regimen (heparin, lmwh, warfarin, or clopidogrel), application of a compression bandage and evacuation of the hematoma.
Approval Order Approval Order
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