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 | 1987-08-21 |
Decision Date | 1987-12-14 |
PMA | P840045 |
Supplement | S003 |
Product Code | LOB |
Advisory Committee | Obstetrics/Gynecology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other Report |
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 |