|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 Name||MEDA-MV PACING SYSTEM|
|Classification Name||implantable pacemaker pulse-generator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for telemetry coil improvement, scamp processor microcode modification, & substitution of dow silastic medical adhesive type a for the loctite used in the attachment of oscillator crystals to ceramics substrates.