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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.
 
Trade NameVARIOUS MODELS ICD'S TMS 1000 PLUS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS024
Date Received06/29/2006
Decision Date07/26/2006
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 Yes
Approval Order Statement 
Approval for programmer software modifications (601. U and a-k00. 8. U) for use in biotronik pacemakers and implantable cardioverter defibrillators. The modifications included adding the 1-opt feature, expanding programmer capabilities, improving printing and data import/export capabilities, enhancing communication and memory, updating programmability and ram and correcting software anomalies. The software is for use with epr 1000 plus programming system, tms 1000 plus programming system and ics 3000 implant control system.
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