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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 NumberS008
Date Received06/24/1999
Decision Date07/09/1999
Product Code
LOB[ Registered Establishments with LOB ]
Advisory Committee Obstetrics/Gynecology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a change in the approved sterilization process of e-beam to gamma radiation process.
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