FDA Registration
Active
🇺🇸 United States
Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Reg #: 2953200
·
FEI: 3001452571
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Medtronic Vascular
- Registration Number
- 2953200
- FEI Number
- 3001452571
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3576 Unocal Pl
- City
- Santa Rosa
- State
- CA
- ZIP
- 95403
- Country
- US
Regulatory Submissions
- PMA Number
- P110013
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2012-02-17 |
Proprietary Names
Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Resolute Integrity MicroTrac Coronary Stent System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility