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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.
 
DevicePHILOS DR/SR/PHILOS II DR /SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/ENTOVIS DR PULSE GENERATORS
Generic NamePulse generator, permanent, implantable
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS086
Date Received08/20/2010
Decision Date09/17/2010
Product Code NVZ 
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  
NEW LABELING SOFTWARE USED TO PRINT THE LABELS FOR VARIOUS DEVICES AND ACCESSORIES.
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