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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-T PULSE GENERATOR AND A-K00.1.U/5 PROGRAMMER SOFTWARE
Generic Nameimplantable pacemaker Pulse-generator
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS037
Date Received02/12/2004
Decision Date03/31/2004
Product Codes DTB DXY KRG 
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 FOR THE ADDITION OF TWO CARDIO REPORT TRIGGERS FOR THE PHILOS DR-T PULSE GENERATOR AND FOR REVISIONS TO THE A-K00.1.U/5 PROGRAMMER SOFTWARE WHICH ARE NECESSARY IN ORDER TO UTILIZE THE MODIFIED PHILOS DR-T.
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