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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 NameLAMICEL(TM)
Classification Namedilator, cervical, synthetic osmotic
Generic Nameosmotic cervical dilator
ApplicantMEDTRONIC XOMED, INC.
PMA NumberP820075
Date Received10/07/1982
Decision Date06/21/1983
Withdrawal Date 01/31/2007
Product Code
LOB[ Registered Establishments with LOB ]
Docket Number 83M-0216
Notice Date 07/19/1983
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S004 S005 S006 S007 
S008 S009 
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