PMA
P820075: LAMICEL(TM)
FDA PMA · Dilator, cervical, synthetic, osmotic, pregnancy termination · Medtronic Xomed, Inc.
Key facts
| PMA number | P820075 |
|---|---|
| Trade name | LAMICEL(TM) |
| Generic name | Dilator, cervical, synthetic, osmotic, pregnancy termination |
| Applicant | Medtronic Xomed, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | LOB |
| Approval date | Jun 21, 1983 |
| Docket number | 83M-0216 |
| Notice date | Jul 19, 1983 |
| Establishment registration | 1045254 |
| FEI number | 1045254 |
At a glance
- 1–9 Supplements
- Jul 16, 1999 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: