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 |