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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.
 
DeviceTHERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BLU DUO ABLATION CATHETER AND 1500TP-CP V1.6 CARDIAC ABLATION GENERATOR
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantAbbott Medical
2375 MORSE AVENUE
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS001
Date Received03/29/2012
Decision Date09/13/2012
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE VENDOR TO SUPPLY PRINTED CIRCUIT BOARDS FOR THE 1500T9-CP V1.6 GENERATOR.
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