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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.
 
DeviceLAMICEL(TM)
Classification Namedilator, cervical, synthetic, osmotic, pregnancy termination
Generic Namedilator, cervical, synthetic, osmotic, pregnancy termination
Applicant
Medtronic Xomed, Inc.
6743 southpoint dr. n.
jacksonville, FL 32216
PMA NumberP820075
Supplement NumberS002
Date Received12/03/1984
Decision Date08/22/1986
Product Code
LOB[ Registered Establishments with LOB ]
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination Product No
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