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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceLAMICEL OSMOTIC 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 NumberS009
Date Received06/24/1999
Decision Date07/16/1999
Product Code
LOB[ Registered Establishments with LOB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new sterilization facility located at sterigenics intl. , inc. , 10811 withers cove park dr. , charlotte, n. C.
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