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 DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T ICDS |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S045 |
Date Received | 04/11/2011 |
Decision Date | 05/26/2011 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS. |
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