PMA
P010055: PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
FDA PMA · System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy · Prostalund AB
Key facts
| PMA number | P010055 |
|---|---|
| Trade name | PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH |
| Generic name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
| Applicant | Prostalund AB |
| Product code | MEQ |
| Approval date | Dec 23, 2002 |
| Docket number | 03M-0189 |
| Notice date | May 9, 2003 |
| FEI number | 3009097182 |
At a glance
- 10–99 Supplements
- Jun 30, 2021 Latest supplement decision
- No Withdrawn
- Yes 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: