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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDILAPAN-S
Classification Namedilator, cervical, synthetic, osmotic, pregnancy termination
Generic Namedilator, cervical, synthetic, osmotic, pregnancy termination
Applicant
MEDICEM TECHNOLOGY S.R.O
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.
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