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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.
 
DeviceDromos DR/SR Rate Adaptive Pacing Systems
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS217
Date Received11/02/2020
Decision Date12/01/2020
Product Code DXY 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Replace 100% Bake and Out Gas testing of electronic module components with lot sampling.
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