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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 NameMODEL 4194 ATTAIN BIPOLAR OVER-THE-WIRE LEAD
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Applicant MEDTRONIC INC.
PMA NumberP010015
Supplement NumberS068
Date Received04/06/2009
Decision Date06/05/2009
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change to the dc resistance specification for the model 4194 attain bipolar over-the-wire (otw) lead family.
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