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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIOTRONIK GEMNOS 04, 04A, AND TC 04
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP820076
Supplement NumberS020
Date Received05/04/1995
Decision Date12/22/1995
Product Code
LWP[ Registered Establishments with LWP ]
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 CHANGE IN THE BURN-IN PROCESSING OF THE WILSON GREATBATCH BATTERIES WHICH ARE USED IN YOUR LISTED PACEMAKERS. THIS PROCESS CHANGE IS A REDUCTION OF THE BATTERY BURN-IN TIME FROM 35 DAYS TO 4 DAYS
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