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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
PMA NumberP000009
Supplement NumberS026
Date Received05/15/2008
Decision Date11/04/2008
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of models 500/540 to the lumax family of icd/crt-ds and ics 3000 programmer. These models would contain: ¿ a third programmable cardioversion / defibrillation shock pathway to offer more programming options ¿ automatic threshold measurement (atm) feature ¿ electronic module (hardware) updates to support the third programmable shock path ¿ modifications to the litronik batteries to increase capacity ¿ new standard value of the programmable pacing pulse width ¿ updated ram firmware to support new features.