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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.
 
DeviceESTELLA AND EFFECTA PULSE GENERATORS
Classification Namepulse generator, permanent, implantable
Generic Namepulse generator, permanent, implantable
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP950037
Supplement NumberS092
Date Received12/13/2010
Decision Date02/11/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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