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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 NameSLX 58/11-BP, SLX 58/13-BP,SLX 58/14-BP,SLX 58/15-BP,SLX 58/17-BP,SLX 65/11-BP,SLX 65/13-BP,SLX 65/14-BP,SLX 65/15-BP,SL
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
PMA NumberP950037
Supplement NumberS149
Date Received03/06/2015
Decision Date07/17/2015
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for implementation of parametric release in place of conventional product release in the sterilization process for permanent pacemaker and defibrillation leads.