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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.
 
DeviceFlexAbility™ Ablation Catheter, Sensor Enabled™
Generic NameCardiac ablation percutaneous catheter
ApplicantAbbott Medical
2375 MORSE AVENUE
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS080
Date Received04/11/2022
Decision Date12/14/2022
Product Codes LPB OAD 
Docket Number 22M-3254
Notice Date 12/20/2022
Advisory Committee Cardiovascular
Clinical TrialsNCT03490201
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expanding the indications to include the treatment of ventricular tachycardia to the current approved device indication for use.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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