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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(R) OSSMOTIC CERVICAL DILATOR
Classification Namedilator, cervical, synthetic osmotic
Generic Namecervical dilator
ApplicantMEROCEL CORP.
PMA NumberP820075
Supplement NumberS006
Date Received05/12/1995
Decision Date10/10/1995
Product Code
LOB[ Registered Establishments with LOB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new accelerated testing protocol to establish the shelf-life of your product to 24 months.
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