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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.
 
DeviceGENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)
Generic NameMonitor, uterine contraction, external (for use in clinic)
Regulation Number884.2720
ApplicantMATRIA HEALTHCARE, INC.
1850 PARKWAY PLACE
SUITE 1200
MARIETTA, GA 30067
PMA NumberP890063
Supplement NumberS004
Date Received04/07/1993
Decision Date06/16/1995
Reclassified Date 04/09/2001
Product Code HFM 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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