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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 CatTactiFlex™ Ablation Catheter, Sensor Enabled™heter, Sensor Enabled™, TactiSys™ Quartz Equipment,
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantABBOTT MEDICAL
5050 Nathan Ln. N.
Plymouth, MN 55442
PMA NumberP220013
Supplement NumberS008
Date Received09/08/2023
Decision Date10/26/2023
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  
Approval for the addition of Centerpiece as an alternative sterilization site for products manufactured at Abbott’s Plymouth, MN; Minnetonka, MN; and Costa Rica sites.
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