Identity
- Trade Name
- PROPEL FDA UDI
- Generic Name
- Drug-eluting paranasal sinus stent FDA UDI
- Device Name
- IMPLANT 70011 PROPEL FDA UDI
- Model / Reference
- 70011 FDA UDI
- Description
- IMPLANT 70011 PROPEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000710279 FDA UDI
- PMA Number
- P100044 FDA UDI
- FDA Product Code
- OWO FDA UDI
- GMDN Term
- Drug-eluting paranasal sinus stent FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Drug-eluting paranasal sinus stent
Propel by Medtronic Xomed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Drug-eluting paranasal sinus stent.
- PROPEL — MEDTRONIC XOMED, INC. · Class III
- PROPEL — MEDTRONIC XOMED, INC. · Class III
- PROPEL — MEDTRONIC XOMED, INC. · Class III
Cleared under the same submission
P100044 also covers:
- PROPEL Mini Sinus Implant with Straight Delivery System — Intersect Ent.
- Propel — Intersect Ent.
- Propel Contour — Intersect Ent.
- Propel Mini — Intersect Ent.
- Propel Mini Straight Delivery System (SDS) Single Unit — Intersect Ent.
- PROPEL — MEDTRONIC XOMED, INC.
- PROPEL — MEDTRONIC XOMED, INC.
- PROPEL — MEDTRONIC XOMED, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI d9ee08ef-26b5-48b0-9db1-a6f9ec9f3f6e 36 fields · synced May 30, 2026