|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 Name||pulse generator, permanent, implantable|
|Generic Name||pulse generator, permanent, implantable|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in pgs and icds.