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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 NumberS003
Date Received06/19/1995
Decision Date12/15/1995
Withdrawal Date12/19/2007
Product Code LTA 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DELETING THE TEST FOR ANTIGENIC IMPURITIES IN THE TESTING SPECIFICATIONS FOR THE DEXTRAN 70 (CODE 59479) BULK DRUG SUBSTANCE
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