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.
| Device | DILAPAN(TM) |
| Generic Name | Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination |
| Applicant | MEDICEM TECHNOLOGY S.R.O |
| Date Received | 1987-08-04 |
| Decision Date | 1988-09-28 |
| PMA | P840045 |
| Supplement | S002 |
| Product Code | LOB |
| Advisory Committee | Obstetrics/Gynecology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |