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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameGENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
Classification Namemonitor, uterine contraction, external (for use in clinic)
Generic Nameuterine contraction monitor
Regulation Number884.2720
ApplicantMATRIA HEALTHCARE, INC.
PMA NumberP890063
Date Received11/15/1989
Decision Date09/12/1990
Reclassified Date 04/09/2001
Product Code
HFM[ Registered Establishments with HFM ]
Docket Number 90M-0315
Notice Date 10/23/1990
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Supplements: S002 S003 S004 
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