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FDA 510(k) Applications Submitted by Abbott (St. Jude Medical)
FDA 510(k) Number
Submission Date
Device Name
Applicant
K212206
07/15/2021
Jot Dx Insertable Cardiac Monitor
Abbott (St. Jude Medical)
K202876
09/28/2020
Confirm Rx Insertable Cardiac Monitor
Abbott (St. Jude Medical)
K190295
02/11/2019
Confirm Rx Insertable Cardiac Monitor
Abbott (St. Jude Medical)
K202888
09/28/2020
Confirm Rx Insertable Cardiac Monitor
Abbott (St. Jude Medical)
K193310
11/29/2019
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
Abbott (St. Jude Medical)
K200721
03/19/2020
Agilis HisPro Steerable Catheter With Electrodes
Abbott (St. Jude Medical)
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