PMA
P840045: DILAPAN-S CERVICAL DILATOR
FDA PMA · Dilator, cervical, synthetic, osmotic, pregnancy termination · Medicem Technology S.R.O
Key facts
| PMA number | P840045 |
|---|---|
| Trade name | DILAPAN-S CERVICAL DILATOR |
| Generic name | Dilator, cervical, synthetic, osmotic, pregnancy termination |
| Applicant | Medicem Technology S.R.O |
| Owner/operator | MEDICEM Technology |
| Product code | LOB |
| Approval date | Apr 28, 1986 |
| Docket number | 86M-0201 |
| Notice date | Jun 11, 1986 |
| Establishment registration | 3003994796 |
| FEI number | 1000573518 |
At a glance
- 1–9 Supplements
- Oct 25, 2002 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: