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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
3333 diamond canyon rd.
diamond bar, CA 91765
PMA NumberP010068
Supplement NumberS031
Date Received11/07/2012
Decision Date06/06/2013
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 modified catheter designs to the 7fr celsius and 7fr ez steer ds catheters to create the 7. 5fr 8 mm celsius fltr catheters. The changes being approved are the increased distal profile, larger curve profile, increased range of deflection, and increased deflectable tip diameter. The devices, as modified, will be marketed under the trade names bi-directional celsius fltr catheters (d-1359-xx-s) and uni-directional celsius fltr catheters (d-1355-xx-s) and are indicated for catheter-based cardiac electrophysiological mapping (stimulation and recording), and when used with the stockert 70 (with software version 001/033 or higher) for the treatment of type i atrial flutter in patients age 18 years of age or older.