DILAPAN
by MEDICEM Technology s.r.o. EUDAMEDPMA
Withdrawn
PMA P840045
Overview
DILAPAN is a synthetic osmotic cervical dilator designed for use in pregnancy termination. It is classified as a Class III dilator and identified in the FDA database as a cervical, synthetic, osmotic device. The product functions by absorbing fluid and expanding to gently dilate the cervix.
The device is manufactured by Medicem Technology s.r.o. and carries FDA PMA, MDD and MDR authorizations, with PMA number P840045 and product code LOB. It is supplied as a sterile, single‑use instrument intended for obstetrics/gynecology procedures, and is regulated as a Class III medical device.
Regulatory status
Withdrawn since 28 Apr 1986. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD PMA | NumberP840045 | Date28 Apr 1986 | StatusWithdrawn |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusWithdrawn |
| European Union | CE/MDR PMA | Number— | Date— | StatusNot known |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Full name
- Dilapan(Tm)
- Trade Name
- Dilapan-S Cervical Dilator
- Generic Name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- FDA applicant
- Medicem Technology S.R.O
- PMA Number
- FDA Product Code
- LOB
- Device Class
- Class III
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- APWD Approval withdrawn
Other devices from MEDICEM Technology s.r.o.
Questions
What material is DILAPAN made from?
DILAPAN is described as a synthetic osmotic dilator, indicating it is made from a synthetic polymer that absorbs fluid and expands. The specification lists the generic name as "dilator, cervical, synthetic, osmotic," confirming the material type.
How is DILAPAN intended to be used?
The device is a cervical dilator for pregnancy termination. It is inserted into the cervical canal where its osmotic properties cause it to swell, gently dilating the cervix to facilitate the termination procedure. This use follows the definition provided in the device specifications.
What regulatory authorizations does DILAPAN have?
DILAPAN is authorized under FDA PMA (Premarket Approval) with PMA number P840045, as well as under the European Medical Device Directive (MDD) and the newer Medical Device Regulation (MDR). These authorizations indicate it has undergone the required regulatory review for a Class III device.
Is DILAPAN a reusable device?
The specifications do not state that DILAPAN is reusable; it is listed as a synthetic osmotic cervical dilator, which are typically supplied sterile and intended for single‑use in obstetric procedures.
What is the product code for DILAPAN?
The FDA product code assigned to DILAPAN is LOB, as indicated in the device data. This code classifies the device within the FDA's system for cervical dilators.