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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.
 
DeviceSTRATOS LV,EVIA HF,EVIA HF-T,ENTOVIS HF,ENTOVIS HF-T,COROX OTW 85 UP STEROID,COROX OTW 75-BP,COROX OTW 85-BP,COROX OTW-S
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP070008
Supplement NumberS038
Date Received01/14/2013
Decision Date02/19/2013
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
RECLASSIFYING THE ENVIRONMENTAL CONDITIONS FROM CLASS D TO ISO 8 CLEANROOMS.
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