DILAPAN-S
FDA premarket approval P840045/S006 · decided 2002-10-25
Approval details
- PMA number
- P840045
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DILAPAN-S
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Applicant
- Medicem Technology S.R.O
- Date received
- 2000-03-31
- Decision date
- 2002-10-25
- Days to decision
- 938 days
- Decision code
- APPR
- Product code
- LOB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Kamenne Zehrovice
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Dilapan-S (K143447) | Medicem Technology S.R.O | 2015-04-17 |