FDA Registration
Active
🇫🇷 France
Streamline Temporary Pacing Leads
Reg #: 9611350
·
FEI: 1000241540
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDTRONIC FABRICATION S.A.S.
- Registration Number
- 9611350
- FEI Number
- 1000241540
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 103 ROUTE D ANOR
- City
- FOURMIES Nord
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K171253
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
US Agent
- Business Name
- MEDTRONIC
- Contact Name
- Ryan Calabrese
- Address
- 8200 Coral Sea St NE # MVS71
- City
- Moundsview
- State
- MN
- ZIP
- 55112
- Country
- US
- [email protected]
- Phone
- 763 5263515
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2017-11-01 |
Proprietary Names
Streamline Temporary Pacing Leads
Establishment Types
Manufacture Medical Device