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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic Namedilator, cervical, synthetic, osmotic, pregnancy termination
ApplicantMedtronic Xomed, Inc.
PMA NumberP820075
Date Received10/07/1982
Decision Date06/21/1983
Withdrawal Date 01/31/2007
Product Code LOB 
Docket Number 83M-0216
Notice Date 07/19/1983
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S002 S004 S005 S006 S007 S008 S009