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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.
Classification Namefluid, hysteroscopy
Generic Namefluid, hysteroscopy
Hospira, Inc.
275 north field dr.
dept. 389, bldg. h2-2
lake forest, IL 60045
PMA NumberP880028
Supplement NumberS003
Date Received06/19/1995
Decision Date12/15/1995
Product Code
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for deleting the test for antigenic impurities in the testing specifications for the dextran 70 (code 59479) bulk drug substance.