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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 NameCAPSURE Z MODELS 5034/5534/5033 PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Nameelectrode, pacemaker, permanent
Regulation Number870.3680
PMA NumberP850089
Supplement NumberS033
Date Received04/06/1995
Decision Date12/21/1995
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for models 5034, 5534, 5033 pacing leads - the devices as modified will be marketed under the trade names capsure z model 5-34, 5534, and 5033 pacing leadsand have applications where permanent ventricular, atrial, or dual chambered pacing systems are indicated. The leads are used to provide channeled, electrically conductive pathwasy between the pulse generator and the heart.