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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 NameRF CONTRACTR/RF CONDUCTR/RF MARINR/RF MARINR 5FR/RF ENHANCER II FAMILIES OF ABLATION CATHETERS
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS035
Date Received11/25/2011
Decision Date12/23/2011
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 
Implementation of the new electrical test systems.
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