PMA
P970044: DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
FDA PMA · System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy · Dornier Medtech America, Inc.
Key facts
| PMA number | P970044 |
|---|---|
| Trade name | DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM |
| Generic name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
| Applicant | Dornier Medtech America, Inc. |
| Owner/operator | Dornier MedTech America, Inc. |
| Product code | MEQ |
| Approval date | May 29, 1998 |
| Docket number | 98M-0403 |
| Notice date | Jun 23, 1998 |
| Establishment registration | 1037955 |
| FEI number | 1037955 |
At a glance
- 1–9 Supplements
- Mar 12, 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- Yes Withdrawn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: