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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
Classification Namefluid, hysteroscopy
Generic Namefluid, hysteroscopy
Applicant
Hospira, Inc.
275 north field dr.
dept. 389, bldg. h2-2
lake forest, IL 60045
PMA NumberP880028
Supplement NumberS001
Date Received07/24/1989
Decision Date12/29/1989
Product Code
LTA
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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