|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||PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNHRONIZATION THERAPY-DEFIBRILLATOR|
|Applicant||BOSTON SCIENTIFIC CORP.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Eliminate an equipment check performed on equipment used to test parylene coating thickness of batteries and capacitors used in the device models.