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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 SYSTEM & TERM GUARD I & TERM GUARD II SYS.
Generic NameMonitor, uterine contraction, external (for use in clinic)
Regulation Number884.2720
ApplicantMatria Healthcare, Inc.
1850 Pkwy. Pl.
Suite 1200
Marietta, GA 30067
PMA NumberP890063
Supplement NumberS002
Date Received12/21/1990
Decision Date04/10/1991
Reclassified Date04/09/2001
Product Code HFM 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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