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 | VNS THERAPY SYSTEM |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S140 |
Date Received | 10/21/2011 |
Decision Date | 12/20/2011 |
Product Codes |
LYJ MUZ |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR : 1) REMOVAL OF THE CR10 AND CR11 TVS DIODES FROM THE PCBA DESIGN; AND 2) A CHANGE TO THE PRINTED CIRCUIT BOARD (PCB) SPECIFICATION TO ACCEPT VIAS (VERTICAL ELECTRICAL CONNECTIONS BETWEEN DIFFERENT LAYERS OF CONDUCTORS ON A PCB) FILLED WITH EPOXY FROM THE PCB VENDOR, WHICH IS CURRENTLY ALLOWED FOR THE MODEL 103/104 PULSE GENERATORS. |
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