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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 CONDUCTR, RF CONTACTR, RF ENHANCER II, RF MARINR, RF MARINR UNIPOLAR
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
ApplicantMEDTRONIC, INC.
PMA NumberP930029
Supplement NumberS037
Date Received11/21/2012
Decision Date12/20/2012
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 manufacturing execution system version 7. 9 at various internal suppliers and final device manufacturing locations.
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