FDA Registration
Active
🇧🇷 Brazil
St. Jude Medical Brasil Ltda.
Reg #: 3001883144
·
FEI: 3001883144
·
Expires 2026
Products
4
Proprietary Names
19
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- St. Jude Medical Brasil Ltda.
- Registration Number
- 3001883144
- FEI Number
- 3001883144
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rua Professor José Vieira de Mendonça, 1301, Bairro Engenho Nogueira
- City
- Belo Horizonte Minas Gerais
- Country
- BR
Regulatory Submissions
- PMA Number
- P040021
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
US Agent
- Business Name
- Alessandra Chaves Sr Manager Structural Heart
- Contact Name
- Alessandra Chaves
- Address
- One Lillehei Plaza,
- City
- Little Canada
- State
- MN
- ZIP
- 55117
- Country
- US
- [email protected]
- Phone
- 651 9555337
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Heart-Valve, Mechanical | LWQ | Class 3 | Unknown | No | 2007-10-16 |
| Heart-Valve, Non-Allograft Tissue | LWR | Class 3 | Unknown | No | 2007-10-16 |
| Replacement Heart-Valve | DYE | Class 3 | Cardiovascular | No | 2007-10-16 |
| Sizer, Heart-Valve, Prosthesis | DTI | Class 1 | Cardiovascular | No | 1996-05-14 |
Proprietary Names
Epic Supra Valve (Aortic)
Epic Plus Supra Valve (Aortic)
Epic Plus Valve (Mitral)
Epic Plus Valve (Aortic)
Epic Valve (Mitral)
Epic Max Valve (Aortic)
Epic Valve (Aortic)
St. Jude Medical Mechanical Heart Valve Sizer Set
Epic Plus Heart Valve Sizer Set
St. Jude Medical Mechanical Heart Valve Individual Sizer (905 sizer set accessory)
SJM Tailor Annuloplasty Ring Sizer Set
Epic Heart Valve Sizer Set
St Jude Medical Bioprosthetic Heart Valve Sizer Set (Biocor, Biocor Supra, Epic, Epic Supra valve sizer set)
Regent Mechanical Heart Valve Sizer Set
Rigid Saddle Ring Sizer Set
Seguin Annuloplasty Ring Sizer Set
Double-ended Handle Sizer Rings (15mm MHV Sizer)
Mechanical Heart Valve Standard Sizer Ring (905 sizer set accessory)
Epic Max Heart Valve Sizer Set
Establishment Types
Manufacture Medical Device