PMA
P020014: ESSURE SYSTEM
FDA PMA · Transcervical contraceptive tubal occlusion device · Bayer Pharma AG
Key facts
| PMA number | P020014 |
|---|---|
| Trade name | ESSURE SYSTEM |
| Generic name | Transcervical contraceptive tubal occlusion device |
| Applicant | Bayer Pharma AG |
| Owner/operator | Bayer Pharma, AG |
| Product code | HHS |
| Approval date | Nov 4, 2002 |
| Docket number | 03M-0175 |
| Notice date | Apr 28, 2003 |
| Establishment registration | 3002808086 |
| FEI number | 3002808086 |
At a glance
- 10–99 Supplements
- Apr 9, 2018 Latest supplement decision
- No Withdrawn
- Yes 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: