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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(R) OSSMOTIC CERVICAL DILATOR
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 NumberS005
Date Received07/05/1991
Decision Date10/09/1991
Product Code
LOB[ Registered Establishments with LOB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
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