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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.
 
DeviceACTROS SLR PULSE GENERATOR
Generic Namepermanent pacemaker Electrode
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS013
Date Received05/08/2000
Decision Date10/13/2000
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR REMOVAL OF THE WARNING LABEL WHICH RECOMMENDED PROGRAMMING DYNAMIC HYSTERESIS ON WHEN THE DEVICE IS PROGRAMMED TO THE VDDR MODE.
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