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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.
 
DeviceTactiSys Quartz Equipment; Ampere Generator
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantSt Jude Medical
One St. Jude Medical Dr.
St. Paul, MN 55117
PMA NumberP130026
Supplement NumberS102
Date Received05/11/2026
Decision Date08/07/2026
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
Approval Order Statement  
approval for firmware changes to the TactiSys Quartz Equipment v1.8.0 and Ampere Generator v1.2.0 to maintain compatibility with the TactiFlex Duo Ablation Catheter, Sensor Enabled™
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