|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|
|Generic Name||dual-chamber adaptive-rate pacemaker|
|Supplement Type||normal 180 day track|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at cosmed of illinois, 1160 northpoint blvd. , waukegan, il 60085. This supplement qualified for review under the pma supplement pilot described in the march 20, 1996 "dear president or ceo" letter regarding changes in manufacturing sites.