Data / Medical devices / United States / Medifocus Inc
Medifocus Inc: FDA-registered device maker in Columbia, MD, United States, 1 PMA approval
Medifocus Inc is registered with the FDA (registration 3009969279) in Columbia, MD, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated February 19, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009969279
- Address
- 9150 Rumsey Road Suite A4, Columbia, MD, United States, 21045
- Owner or operator
- Medifocus Inc (10042433)
- Roles
- Specification developer
- First device listed
- November 27, 2012
- Registered through
- 2026
- Brand names listed
- Prolieve Thermodilatation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy | MEQ | 3 | Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 19, 2004 | P030006 | PROLIEVE THERMODILATATION SYSTEM | MEQ | 28 | November 21, 2018 | accessdata.fda.gov |
Compare with other makers
Updated November 21, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.