PMA supplement
P840045 S002: DILAPAN(TM)
FDA PMA supplement · Normal 180 Day Track · Medicem Technology S.R.O
Key facts
| Original PMA | P840045 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | DILAPAN(TM) |
| Generic name | Dilator, cervical, synthetic, osmotic, pregnancy termination |
| Applicant | Medicem Technology S.R.O |
| Product code | LOB |
| Received date | Aug 4, 1987 |
| Decision date | Sep 28, 1988 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: