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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 / FlexAbility Ablation Catheter, Sensor Enabled (SE)
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantABBOTT MEDICAL
2375 Morse Ave.
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS081
Date Received11/14/2022
Decision Date12/08/2022
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Alternate tier 3 supplier of resin for the FlexAbility/FlexAbility SE Ablation Catheters, TactiCath SE Ablation Catheter, Livewire TC Ablation Catheter, and Safire Ablation Catheter.
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