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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 Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
6024 jean road
lake oswego, OR 97035
PMA NumberP980023
Supplement NumberS031
Date Received05/14/2008
Decision Date11/04/2008
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
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-dsand ics 3000 programmer. These models would contain:¿ a third programmable cardioversion / defibrillation shock pathway to offer moreprogramming 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.