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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.
 
DeviceSELECTSECURE LEAD
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP030036
Supplement NumberS014
Date Received01/15/2010
Decision Date03/16/2010
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for reformulation of the hotmelt adhesive that is used in medtronic crdm sterile barrier packages.
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