|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||implantable rate-responsive cardiac pacemaker & programmer|
|Applicant||SORIN CRM USA, INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Clean room layout modifications of saluggia, italy plant.