Identity
- Trade Name
- DiamondTemp™ Bidirectional Ablation Catheter FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system catheter FDA UDI
- Device Name
- CATH CEDTB400L BIDIR LG CURVE US FDA UDI
- Model / Reference
- CEDTB400L FDA UDI
- Description
- CATH CEDTB400L BIDIR LG CURVE US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000482138 FDA UDI
- PMA Number
- P200028 FDA UDI
- FDA Product Code
- OAE FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation 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
- Tip Bend Radius — 63.0 Millimeter FDA UDICatheter Length — 110.0 Centimeter FDA UDIOuter Diameter — 2.67 Millimeter FDA UDI
Category: Cardiac radio-frequency ablation system catheter
DiamondTemp™ Bidirectional Ablation Catheter by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P200028 also covers:
- DiamondTemp™ EGM cable — MEDTRONIC NAVIGATION, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Catheter-to-RFG Cable — MEDTRONIC, INC.
- DiamondTemp™ Catheter-to-RFG Cable — MEDTRONIC, INC.
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC.
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC.
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC.
- DiamondTemp™ Foot Switch — 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 2994efd9-6deb-4fc7-bb6d-3f128b684745 37 fields · synced Jun 1, 2026