FDA Registration
Active
🇮🇳 India
InterStim Neurostimulator
Reg #: 3018094310
·
FEI: 3018094310
·
Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Medtronic Engineering and Innovation Center (MEIC)
- Registration Number
- 3018094310
- FEI Number
- 3018094310
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BSR Tech Park, Survey No.135, 138, 141 & 142 Nanakramguda Main Road
- City
- Hyderabad
- Country
- IN
Regulatory Submissions
- PMA Number
- P970004
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, INC.
- Contact Name
- Tania Pearson
- Address
- 3576 Unocal Pl
- City
- Santa Rosa
- State
- CA
- ZIP
- 95403
- Country
- US
- [email protected]
- Phone
- 916 8138456
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Implantable, For Incontinence | EZW | Class 3 | Gastroenterology, Urology | No | 2007-12-26 |
Proprietary Names
InterStim Neurostimulator
Verify External Neurostimulator
InterStim Sacral Nerve Stimulation
InterStim II Sacral Nerve Stim
N'Vision Software Application Card
Verify Evaluation System
Verify Controller
InterStim iCon Patient Programmer
InterStim II Neurostimulator
N'Vision Programmer
InterStim SureScan MRI leads
InterStim Micro Implantable Neurostimulator
InterStim X Implantable Neurostimulator
Establishment Types
Complaint File Establishment per 21 CFR 820.198