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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 FAMILY OF PULSE GENERATORS
Generic Namepermanent pacemaker Electrode
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS016
Date Received10/06/2000
Decision Date10/31/2000
Product Codes DTB DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF ALTERNATIVE COMPONENTS IN THE PHILOS FAMILY OF PULSE GENERATORS, SPECIFICALLY: 1) THE LITRONIK GMBH AND CO. MODEL LIS 3150 BATTERY; AND 2) A LOW TEMPERATURE CO-FIRE CERAMIC (LTCC) SUBSTRATE.
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