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 GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC) |
Generic Name | Stimulator, autonomic nerve, implanted (depression) |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S169 |
Date Received | 04/04/2014 |
Decision Date | 07/02/2014 |
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 A CHANGE TO THE PRINTED CIRCUIT BOARD ASSEMBLYMANUFACTURING DESIGN REQUIREMENT FOR VOLTAGE MEASUREMENT ACCURACY AND TOLERANCE ASSOCIATED WITH ITS ELECTRICAL TESTING. |
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