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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 OSMOTIC CERVICAL DILATOR
Generic Namedilator, cervical, synthetic, osmotic, pregnancy termination
ApplicantMedtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville, FL 32216
PMA NumberP820075
Supplement NumberS009
Date Received06/24/1999
Decision Date07/16/1999
Withdrawal Date01/31/2007
Product Code LOB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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