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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
Generic Namedilator, cervical, synthetic, osmotic, pregnancy termination
ApplicantMedtronic Xomed, Inc.
6743 SOUTHPOINT DR. N.
JACKSONVILLE, FL 32216
PMA NumberP820075
Supplement NumberS006
Date Received05/12/1995
Decision Date10/10/1995
Withdrawal Date 01/31/2007
Product Code LOB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR NEW ACCELERATED TESTING PROTOCOL TO ESTABLISH THE SHELF-LIFE OF YOUR PRODUCT TO 24 MONTHS
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