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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceDEXTRAN HM 32%
Classification Namefluid, hysteroscopy
Generic Namefluid, hysteroscopy
Hospira, Inc.
275 north field dr.
dept. 389, bldg. h2-2
lake forest, IL 60045
PMA NumberP880028
Date Received04/12/1988
Decision Date05/30/1989
Withdrawal Date 12/19/2007
Product Code
Docket Number 89M-0194
Notice Date 06/29/1989
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S006 S007 S008