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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 NameCATH RF CONDUCTR/5 MM 8FR/RF MC 078 6022/CONTACTR CATHETER 7 FR 5MM/RF CONDUCTR MC SELF-REFERENCE CATHETER/RF ENHANCR II
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation system
Applicant MEDTRONIC INC.
PMA NumberP930029
Supplement NumberS029
Date Received04/26/2011
Decision Date05/19/2011
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 
Use of mes web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders.
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