|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||VIGOR(TM) DR PACEMAKER SYSTEM|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Alternate sterilization facility located at cosmed of illinois, 1160 northpoint blvd. , waukegan, il 60085 - this supplement was reviewed under the pilot program and the approval applies only to the request for a new sterilization facility.