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.
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.
| Device | 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 |
| PMA | P840045 |
| Supplement | S006 |
| Product Code | LOB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDICEM TECHNOLOGY S.R.O karlovarsha Trida 20 kamenne Zehrovice 27301 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840045 | Original 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 |