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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.
 
DevicePGR-EIA MONOCLONAL
Generic NameKIT, ASSAY, PROGESTERONE RECEPTOR
Regulation Number864.1860
ApplicantAbbott Laboratories
200 ABBOTT PARK RD.
ABBOTT PARK,, IL 60064-3537
PMA NumberP900013
Supplement NumberS002
Date Received09/16/1999
Decision Date09/22/1999
Withdrawal Date 07/26/2004
Product Code LPI 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling.
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