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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 NameMEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD
Classification Namepermanent pacemaker electrode
Generic Namepacing lead
Regulation Number870.3680
ApplicantMEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP930039
Supplement NumberS002
Date Received06/24/1996
Decision Date01/02/1997
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of model 4067, 4568, 5067, 5068 and 5568 to the capsurefix(r) line. These lead models will also be distributed by viatron, inc. , under the tradename "pirout" (models imu49, imu49jb, imx49, imx49b and imu49jb).
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