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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceDiamondTemp Ablation System
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant
Medtronic Inc.
8200 coral sea street
mounds view, MN 55112
PMA NumberP200028
Date Received06/15/2020
Decision Date01/28/2021
Product Code OAE 
Docket Number 21M-0135
Notice Date 02/01/2021
Advisory Committee Cardiovascular
Clinical Trials NCT02821351
Expedited Review Granted? No
Combination Product No
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 
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