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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 NameIMPLANTABLE CV DEFIBRILLATOR/PACEMAKER PROGRAMMER/ICD MONITORING SYSTEM
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cv defibrillator/pacemaker programmer/icd monitoring system
ApplicantBIOTRONIK, INC.
PMA NumberP000009
Supplement NumberS043
Date Received12/14/2010
Decision Date02/11/2011
Product Code
MRM[ Registered Establishments with MRM ]
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 the ics 3000 programmer application software version psw 1004. U, and the estella dr; estella dr-t; estella sr; estella sr-t; ecuro dr; ecuro dr-t; ecuro sr; ecuro sr-t; effecta d; effecta dr; effecta s; and effecta sr. The device, as modified will be marketed under the trade names listed above, and is indicated for the approved indication for use.
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