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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(TM)
Generic Namedilator, cervical, synthetic, osmotic, pregnancy termination
ApplicantMedicem Technology S.R.O
Karlovarsha Trida 20
Kamenne Zehrovice 27301
PMA NumberP840045
Supplement NumberS003
Date Received08/21/1987
Decision Date12/14/1987
Withdrawal Date06/15/2015
Product Code LOB 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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