| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | DiamondTemp Ablation System |
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| Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
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| Applicant | Medtronic Inc.
8200 Coral Sea Street
Mounds View, MN 55112 |
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| PMA Number | P200028 |
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| Date Received | 06/15/2020 |
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| Decision Date | 01/28/2021 |
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| Product Code |
OAE |
| Docket Number | 21M-0135 |
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| Notice Date | 02/01/2021 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT02821351
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
Approval for the DiamondTemp Catheter is indicated for use in cardiac electrophysiological mapping(stimulation and recording) and for treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation when used in conjunction with the DiamondTemp RF Generator and accessories (DiamondTemp Catheter-to-RF Generator Cable, DiamondTemp GenConnect Cable, DiamondTemp EGM Cable, DiamondTemp Irrigation Pump, DiamondTemp Irrigation Tubing Set) and compatible mapping system. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S005 S011 S007 S018 S022 S013 S009 S010 S020 S021 S015
S016 S017 S001 S002 S003 S004 S014 S012 S006 S008 S023 |
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