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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 BIDIRECTIONAL ABLATION CATHETER
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation catheter
ApplicantST. JUDE MEDICAL
PMA NumberP960016
Supplement NumberS020
Date Received11/01/2007
Decision Date12/19/2007
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design changes to the outer shell of the upper and lower handle components.
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