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 | LUMOS VR/DR (-T) AND LEXOS DR/VR (-T) ICD'S |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S025 |
Date Received | 01/15/2008 |
Decision Date | 03/10/2008 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO: 1) GEOMETRICAL DIMENSIONS OF THE FLANGE OF THE FEEDTHROUGH; AND 2) INSULATING GLASS TYPE 8455 HAS BEEN REPLACED BY GLASS TYPE 8250. |
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