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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.
 
Trade NameGENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM ("HUAM")
Classification Namemonitor, uterine contraction, external (for use in clinic)
Generic Nameuterine contraction monitor
Regulation Number884.2720
ApplicantMATRIA HEALTHCARE, INC.
PMA NumberP890063
Supplement NumberS004
Date Received04/07/1993
Decision Date06/16/1995
Product Code
HFM[ Registered Establishments with HFM ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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