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. |
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Device | LEXOS AND LUMOS ICDS & XELOS DR-T ICD |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S024 |
Date Received | 10/26/2007 |
Decision Date | 03/11/2008 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE CHEMICAL FORMULATION OF THE MANGANESE BINDING AGENT USED IN THE CONSTRUCTION OF BATTERIES TO PTFE DISPERSION DYNEON TF 5032 R. |
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