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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
150 baytech drive
san jose, CA 95134
PMA NumberP020025
Supplement NumberS004
Date Received12/18/2003
Decision Date06/09/2004
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in design of the ept-1000 xp cardiac ablation controller. The change in design incorporates the originally approved ept-1000 xp controller with track while ablate (twa) technology to visualize catheter navigation during rf energy delivery using the real time position management (rpm) system. The device, as modified, will be marketed under the trade name track while ablate (twa) ept-1000 xp cardiac ablation system. The twa ept-1000 xp cardiac ablation controller and accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.