Data / Medical devices / Brazil / St. Jude Medical Brasil Ltda.
St. Jude Medical Brasil Ltda.: FDA-registered device maker in Belo Horizonte Minas Gerais, Brazil, 1 PMA approval
St. Jude Medical Brasil Ltda. is registered with the FDA (registration 3001883144) in Belo Horizonte Minas Gerais, Brazil. It lists 4 device types. The FDA files 1 PMA approval under its listings, the newest dated August 5, 2005. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3001883144
- Address
- Rua Professor José Vieira de Mendonça, 1301 Bairro Engenho Nogueira, Belo Horizonte Minas Gerais, Brazil, 31.310-260
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer
- First device listed
- May 14, 1996
- Registered through
- 2026
- Brand names listed
- Double-ended Handle Sizer Rings (15mm MHV Sizer), Epic Elite Mitral Heart Valve Sizer Set, Epic Elite, Epic Elite Aortic Sizer Set, Epic Heart Valve Sizer Set, Epic Max Heart Valve Sizer Set, Epic Max Valve (Aortic), Epic Plus Heart Valve Sizer Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Heart-Valve, Mechanical | LWQ | 3 | Manufacturer | accessdata.fda.gov |
| Heart-Valve, Non-Allograft Tissue | LWR | 3 | Manufacturer | accessdata.fda.gov |
| Replacement Heart-Valve | DYE | 3 | Manufacturer | accessdata.fda.gov |
| Sizer, Heart-Valve, Prosthesis | DTI | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 5, 2005 | P040021 | SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE | LWR | 60 | September 18, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Heart-Valve, Mechanical
- All makers of Heart-Valve, Non-Allograft Tissue
- All makers of Replacement Heart-Valve
- All makers of Sizer, Heart-Valve, Prosthesis
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.