PMA
P920046: FILSHIE CLIP (MARK VI) SYSTEM
FDA PMA · Laparoscopic contraceptive tubal occlusion device · Femcare, Ltd.
Key facts
| PMA number | P920046 |
|---|---|
| Trade name | FILSHIE CLIP (MARK VI) SYSTEM |
| Generic name | Laparoscopic contraceptive tubal occlusion device |
| Applicant | Femcare , Ltd. |
| Owner/operator | FEMCARE LTD. |
| Product code | KNH |
| Approval date | Sep 5, 1996 |
| Docket number | 96M-0463 |
| Notice date | Dec 9, 1996 |
| Establishment registration | 8021955 |
| FEI number | 3002806976 |
At a glance
- 10–99 Supplements
- Dec 3, 2024 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: