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DiamondTemp™ FASTR RF Generator
FDA UDIEUDAMEDClass III (US FDA UDI)
Ref CEDTG200Ref CEDTC100
Identity
- Trade Name
- DiamondTemp™ EUDAMEDDiamondTemp™ FASTR RF Generator FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system generator FDA UDI
- Device Name
- DiamondTemp Generator EUDAMEDDiamondTemp Cath-to-RFG Cable EUDAMEDGENERATOR CEDTG200 FASTR RF US FDA UDIGENERATOR CEDTG200 FASTR RF US/CAN FDA UDI
- Model / Reference
- CEDTG200 EUDAMEDFDA UDICEDTC100 EUDAMED
- Description
- GENERATOR CEDTG200 FASTR RF US FDA UDIGENERATOR CEDTG200 FASTR RF US/CAN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000540746 EUDAMED00763000540913 EUDAMED00763000708917 FDA UDI00763000687960 FDA UDI
- Basic UDI-DI
- 0763000B000085187 EUDAMED0763000B000085289 EUDAMED
- PMA Number
- P200028 FDA UDI
- FDA Product Code
- OAE FDA UDI
- EMDN Code
- Z12059011 CARDIAC ABLATION EQUIPMENT EUDAMEDC0280 ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Cardiac radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMED
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac radio-frequency ablation system generator
DiamondTemp™ FASTR RF Generator by Medtronic, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac radio-frequency ablation system generator.
- nContact RF Generator — ATRICURE, INC. · Class II
- INTELLAGEN™ Remote Control — Stockert GmbH · Class III
- Isolator Surgical Ablation System — ATRICURE, INC. · Class II
- Ampere™ — ST. JUDE MEDICAL, INC. · Class III
- AtriCure Isolator Synergy EnCompass Clamp and Guide System — ATRICURE, INC. · Class II
- Subtle Cannula with Guide — ATRICURE, INC. · Class I
- Synergy™ Ablation System — ATRICURE, INC. · Class III
- Ampere™ — ST. JUDE MEDICAL, INC. · Class III
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™ 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™ Foot Switch — MEDTRONIC, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (4)
- FDA UDI 385544f8-ca71-4cef-9339-6d54026b9e5a 36 fields · synced Sep 17, 2026
- FDA UDI b7f42d29-fb3d-4f73-8ff6-34d032649b07 36 fields · synced May 26, 2026
- EUDAMED c24d99a9-16ba-49a3-82f8-ea7451e665c2 61 fields · synced Sep 17, 2026
- EUDAMED 83977cf4-5628-4f89-b5c1-4ea76f80d77d 61 fields · synced Sep 17, 2026