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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.
Classification Namepermanent defibrillator electrodes
PMA NumberP030036
Supplement NumberS013
Date Received03/17/2009
Decision Date04/28/2009
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new kit containing individually packaged lead anchoring sleeves. The kit will be marketed under the trade name model 5867 as anchoring sleeve kit and is intended for use with the medtronic implantable endocardial lead families listed.