PMA P840045S006

Device: DILAPAN-S
Applicant: Medicem Technology S.R.O
PMA number: P840045
Supplement: S006
Product code: LOB
Decision date: 2002-10-25
Generic name: dilator, cervical, synthetic, osmotic, pregnancy termination
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.

Current openFDA PMA Record#

Device: DILAPAN-S
Applicant: Medicem Technology S.R.O
PMA number: P840045
Supplement: S006
Product code: LOB
Generic name: dilator, cervical, synthetic, osmotic, pregnancy termination
Decision date: 2002-10-25
Decision code: APPR
Date received: 2000-03-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.