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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 SYSTEM
Generic NamePulse generator, permanent, implantable
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS108
Date Received04/05/2012
Decision Date05/17/2012
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD A COPPER ALLOY SHIELDING PLATE TO BE APPLIED OVER THE HOUSING OF A QUARTZ CRYSTAL ON THE PCB AND UPDATE THE DEVICE LABELING. THE PURPOSE FOR THESE MODIFICATIONS IS TO IMPROVE PERFORMANCE DURING RF CAUTERY.
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