PMA
P010059: MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C
FDA PMA · Ring, endocapsular · Morcher GmbH
Key facts
| PMA number | P010059 |
|---|---|
| Trade name | MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C |
| Generic name | Ring, endocapsular |
| Applicant | Morcher GmbH |
| Owner/operator | MORCHER GMBH |
| Product code | MRJ |
| Approval date | Oct 23, 2003 |
| Docket number | 04M-0022 |
| Notice date | Jan 21, 2004 |
| Establishment registration | 9617458 |
| FEI number | 1000447964 |
At a glance
- 10–99 Supplements
- Nov 4, 2024 Latest supplement decision
- No Withdrawn
- Yes 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: