DILAPAN-S

FDA Premarket Approval P840045 S006

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.

Pre-market Approval Supplement Details

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.

DeviceDILAPAN-S
Generic NameDilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
ApplicantMEDICEM TECHNOLOGY S.R.O
Date Received2000-03-31
Decision Date2002-10-25
PMAP840045
SupplementS006
Product CodeLOB 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MEDICEM TECHNOLOGY S.R.O karlovarsha Trida 20 kamenne Zehrovice 27301

Supplemental Filings

Supplement NumberDateSupplement Type
P840045Original Filing
S006 2000-03-31 Normal 180 Day Track
S005
S004
S003 1987-08-21 Normal 180 Day Track
S002 1987-08-04 Normal 180 Day Track
S001

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