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. |
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Device | DILAPAN-S |
Generic Name | dilator, cervical, synthetic, osmotic, pregnancy termination |
Applicant | MEDICEM TECHNOLOGY S.R.O KARLOVARSHA TRIDA 20 KAMENNE ZEHROVICE 27301 |
PMA Number | P840045 |
Supplement Number | S006 |
Date Received | 03/31/2000 |
Decision Date | 10/25/2002 |
Withdrawal Date
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06/15/2015 |
Product Code |
LOB |
Advisory Committee |
Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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