Identity
- Trade Name
- Arctic Front Advance Pro™ FDA UDI
- Generic Name
- Cardiac cryosurgical system catheter FDA UDI
- Device Name
- CATH AFAPRO28 AFA PRO 28 US MVC FDA UDI
- Model / Reference
- AFAPRO28 FDA UDI
- Description
- CATH AFAPRO28 AFA PRO 28 US MVC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000707781 FDA UDI
- PMA Number
- P100010 FDA UDI
- FDA Product Code
- OAE FDA UDI
- GMDN Term
- Cardiac cryosurgical system catheter 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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
Dimensions & Sizes
- Size
- Catheter Working Length — 95.0 Centimeter FDA UDICatheter Gauge — 10.5 French FDA UDI
Category: Cardiac cryosurgical system catheter
Arctic Front Advance Pro™ by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac cryosurgical system catheter.
- POLARx™ FIT — Boston Scientific · Class III
- POLARx™ — Boston Scientific · Class III
- POLARx™ — Boston Scientific · Class III
- POLARx™ FIT — Boston Scientific · Class III
- Freezor™ Xtra — MEDTRONIC, INC. · Class III
- Freezor® Xtra — MEDTRONIC, INC. · Class III
- Arctic Front Advance™ — MEDTRONIC, INC. · Class III
- Freezor® MAX — MEDTRONIC, INC. · Class III
Cleared under the same submission
P100010 also covers:
- Arctic Front Advance Pro™ — MEDTRONIC, INC.
- Arctic Front Advance Pro™ — MEDTRONIC, INC.
- Arctic Front Advance Pro™ — MEDTRONIC, INC.
- Arctic Front Advance Pro™ — MEDTRONIC, INC.
- Arctic Front Advance Pro™ — MEDTRONIC, INC.
- Arctic Front Advance Pro™ — MEDTRONIC, INC.
- Arctic Front Advance Pro™ — MEDTRONIC, INC.
- Arctic Front Advance™ — MEDTRONIC, INC.
- Arctic Front Advance™ — MEDTRONIC, INC.
- Arctic Front Advance™ — MEDTRONIC, INC.
- Arctic Front Advance™ — MEDTRONIC, INC.
- Arctic Front Advance™ — MEDTRONIC, 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, Inc.
Sources (1)
- FDA UDI 0fe0a8c1-b5fd-478b-8400-2433f0790e5f 37 fields · synced May 30, 2026