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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
St. Jude Medical, Inc.
2375 morse avenue
irvine, CA 92614-6233
PMA NumberP110016
Supplement NumberS002
Date Received05/11/2012
Decision Date07/10/2012
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative package configuration for the subject ablation catheters. The new package configuration would change the previous coiled tray configuration to a tray with a straight configuration. The device, as modified, will be marketed under the trade names safire blu sp irrigated ablation catheter, therapy cool path sp (bi-directional) ablation catheter, and safire blu duo sp ablation catheter.