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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.
Classification Namedilator, cervical, synthetic, osmotic, pregnancy termination
Generic Namedilator, cervical, synthetic, osmotic, pregnancy termination
PMA NumberP840045
Supplement NumberS006
Date Received03/31/2000
Decision Date10/25/2002
Product Code
LOB[ Registered Establishments with LOB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new device design and new manufacturing location. The device, as modified and with revised labeling, will be marketed under the trade name dilapan-s and is indicated for dilatation of the cervix uteri prior to termination of pregnancy up to 16 weeks gestation. A single dilapan-s is inserted into the endocervical canal and may remain in situ for up to four hours. The device will be manufactured at a new facility located at gelmed international, in the czech republic and sterilized at a contract sterilization facility located at bioster a. S. , in the czech republic.