FDA Registration
Active
🇺🇸 United States
Propel Mini Sinus Implant with Straight Deliver System (SDS)
Reg #: 3008301917
·
FEI: 3008301917
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INTERSECT ENT
- Registration Number
- 3008301917
- FEI Number
- 3008301917
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1555 Adams Dr
- City
- Menlo Park
- State
- CA
- ZIP
- 94025
- Country
- US
Regulatory Submissions
- PMA Number
- P100044
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 |
|---|---|---|---|---|---|
| Drug-Eluting Sinus Stent | OWO | Class 3 | Unknown | No | 2022-11-10 |
Proprietary Names
Propel Mini Sinus Implant with Straight Deliver System (SDS)
Propel Contour Sinus Implant
Propel Mini Sinus Implant
Propel Sinus Implant
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device