DiamondTemp Ablation Catheters

FDA Premarket Approval P200028 S001

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 changes to the visual inspection methodology and acceptance criteria for a laser welding process

DeviceDiamondTemp Ablation Catheters
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantMedtronic Inc.
Date Received2021-02-08
Decision Date2021-03-08
Product CodeOAE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Inc. 8200 Coral Sea Street mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P200028Original Filing
S001 2021-02-08 30-day Notice

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