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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
karlovarsha trida 20
kamenne zehrovice 27301
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.