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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.
 
DevicePROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT
Generic Namepermanent pacemaker Electrode
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS032
Date Received02/28/2003
Decision Date03/31/2004
Product Codes DTB DXY KRG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING AXVX ADAPTIVE RATE PACING CAPABILITY TO THE PROTOS FAMILY OF PULSE GENERATORS, THE ADDITION OF THE DATA TRANSFER UTILITY SOFTWARE, AND MODIFICATIONS TO THE AXIOS FAMILY OF PULSE GENERATORS.
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