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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) OSMOSTIC 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 NumberS007
Date Received05/22/1995
Decision Date01/03/1996
Product Code
LOB[ Registered Establishments with LOB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR RELOCATING CABOT'S LAMICEL PROCESSING EQUIPMENT AND THE ASSOCIATED METHODS OR PROCEDURESTO THE MEROCEL FACILITY AT 950 FLANDERS ROAD, MYSTIC, CONNECTICUT, 06355
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