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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 NameSUREFIX TM MODEL 5072 LEAD
Classification Namepermanent pacemaker electrode
Generic Namepacing lead
Regulation Number870.3680
ApplicantMEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP930039
Supplement NumberS006
Date Received04/20/1998
Decision Date08/12/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site lcoated at medtronic puerto rico, inc. , (mpri), road 149, rm. 56. 3, villalba, puerto rico 00755.
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