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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM
Generic NameFLUID, HYSTEROSCOPY
ApplicantHospira, Inc.
275 NORTH FIELD DR.
DEPT. 389, BLDG. H2-2
LAKE FOREST, IL 60045
PMA NumberP880028
Supplement NumberS007
Date Received04/02/1996
Decision Date09/05/1996
Withdrawal Date 12/19/2007
Product Code LTA 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ALLOW FOR THE ROUTINE PARAMETRIC RELEASE OF TERMINALLY MOIST-HEAT STERILIZED SOLUTIONS BY THE OCNTROL OF PROCESS PARAMETERS FOR DEXTROSE HM 32%
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