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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.
 
Trade NameSAFIRE CARDIAC ABLATION SYSTEM
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS025
Date Received10/28/2009
Decision Date11/20/2009
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to an automated manufacturing process, a change in a welding process and a change to process monitoring testing.
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