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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.
 
DeviceSAFIRE BLU DUO SP ABLATION CATHETERS
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantAbbott Medical
2375 MORSE AVENUE
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS002
Date Received05/11/2012
Decision Date07/10/2012
Product Code OAD 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
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.
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