PMA
P870076: FALOPE RING BAND AND APPLICATOR SYSTEMS
FDA PMA · Laparoscopic contraceptive tubal occlusion device · Gyrus Acmi, Inc.
Key facts
| PMA number | P870076 |
|---|---|
| Trade name | FALOPE RING BAND AND APPLICATOR SYSTEMS |
| Generic name | Laparoscopic contraceptive tubal occlusion device |
| Applicant | Gyrus Acmi, Inc. |
| Owner/operator | OLYMPUS CORPORATION |
| Product code | KNH |
| Approval date | Sep 29, 1993 |
| Docket number | 93M-0381 |
| Notice date | Nov 10, 1993 |
| Establishment registration | 3003790304 |
| FEI number | 3003790304 |
At a glance
- 10–99 Supplements
- May 19, 2021 Latest supplement decision
- No Withdrawn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: