DiamondTemp Ablation Catheters

FDA Premarket Approval P200028 S006

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.

Pre-market Approval Supplement Details

Approval for a correction to the catheter diameter in the device labels and labeling

DeviceDiamondTemp Ablation Catheters
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantMedtronic Inc.
Date Received2021-04-20
Decision Date2021-05-19
Product CodeOAE 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Inc. 8200 Coral Sea Street mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P200028Original Filing
S006 2021-04-20 Special (immediate Track)
S001 2021-02-08 30-day Notice

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