|Trade Name||ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||implantable cardioverter defibrillator,pacemaker programmer;icd monitoring system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the pcmcia software cartridge including an increase in memory. The device, as modified, will be marketed under the trade name ata software cartridge (swm 1000 i-ktb. 0. U) and is intended to allow interrogation and programming of biotronik icd's and pacemakers.