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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDiamondTemp Ablation System
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantMedtronic, Inc.
8200 Coral Sea St.
Mounds View, MN 55112
PMA NumberP200028
Supplement NumberS013
Date Received09/23/2022
Decision Date12/13/2022
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the release of a Universal Serial Bus (USB) tool to upgrade commercially distributed Radiofrequency (RF) Generator (CEDTG200) units from software V1.31 to V1.41.
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