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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.
 
DevicePHYLAX AV ICD SYSTEM
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS062
Date Received03/23/2015
Decision Date06/19/2015
Product Codes NIK LWS NVZ NKE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE QP CRT-D DEVICE MODELS WITH ONE IS4 PORT, ONE IS-1 PORT AND ONE DF4 PORT ALONG WITH A UPDATED SOFTWARE ¿ PSW 1502.U FOR THE DEVICES.
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