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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 ABLATION CATHETERS
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
ApplicantABBOTT MEDICAL
2375 Morse Ave.
Plymouth, MN 55442
PMA NumberP110016
Supplement NumberS005
Date Received07/11/2012
Decision Date11/29/2012
Product Code OAD 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE SUPPLIER OF THE CATHETER SHAFT SUBASSEMBLY.
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