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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.
 
DeviceTactiFlex™ Ablation Catheter, Sensor Enabled™
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantABBOTT MEDICAL
5050 Nathan Ln. N.
Plymouth, MN 55442
PMA NumberP220013
Supplement NumberS011
Date Received03/15/2024
Decision Date03/05/2025
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to add Midwest Sterilization Corporation (Midwest) as an ethylene oxide (EO) sterilization vendor for the TactiFlex Ablation Catheter at the Midwest Jackson, MO facility.
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