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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,pacemaker programmer;icd monitoring system
PMA NumberP980023
Supplement NumberS010
Date Received07/22/2002
Decision Date08/30/2002
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product 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.