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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.
 
Trade NameLAMICEL OSMOTIC CERVICAL DILATOR
Classification Namedilator, cervical, synthetic osmotic
Generic Namecervical dilator
ApplicantMEDTRONIC XOMED, INC.
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: sterilization
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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