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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 Catheters (Bi & Uni Directional)
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantABBOTT MEDICAL
2375 Morse Ave.
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS034
Date Received06/24/2016
Decision Date09/29/2017
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the tip-to-shaft adhesive bond assembly process utilized in the distal shaft of the FlexAbility Ablation Catheters (Bi-Directional and Uni-Directional).
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