DiamondTemp Ablation System

FDA Premarket Approval P200028

Pre-market Approval Supplement Details

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.

DeviceDiamondTemp Ablation System
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantMedtronic Inc.
Date Received2020-06-15
Decision Date2021-01-28
PMAP200028
SupplementS
Product CodeOAE 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Inc. 8200 Coral Sea Street mounds View, MN 55112

Supplemental Filings

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Supplement NumberDateSupplement Type
P200028Original Filing

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