Data / Medical devices / United States / Medalliance, LLC
Medalliance, LLC: FDA-registered device maker in Irvine, CA, United States, 1 PMA approval
Medalliance, LLC is registered with the FDA (registration 3015190176) in Irvine, CA, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated September 18, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015190176
- Address
- 4 Jenner Suite 190, Irvine, CA, United States, 92618
- Owner or operator
- MedAlliance, LLC (10060623)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- December 9, 2022
- Registered through
- 2026
- Brand names listed
- SELUTION SLR 014 PTCA BALLOON CATHETER, SELUTION SLR 018 PTA BALLOON CATHETER, SELUTION SLR 014 PTCA Drug-Eluting Balloon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter | OOB | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | 3 | Manufacturer for export | 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 |
|---|---|---|---|---|---|---|
| September 18, 2026 | P250041 | SELUTION SLR 014 PTCA Drug-Eluting Balloon | OOB | 0 | September 18, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- All makers of Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
Updated September 18, 2026. 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.