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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 N. Field Dr.
Dept. 389, Bldg. H2-2
Lake Forest, IL 60045
PMA NumberP880028
Supplement NumberS006
Date Received11/17/1995
Decision Date01/04/1996
Withdrawal Date12/19/2007
Product Code LTA 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ALTERNATE MANUFACTURING FACILITY WITH ROQUEETE AMERICA, INC. IN KEOKUK, IOWA, FOR DEXTROSE USP. HYDROUS BULK DRUG AS A COMPONENT OF DEXTROSE HM 32%
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