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 | PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105 |
Generic Name | Stimulator, autonomic nerve, implanted (depression) |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S176 |
Date Received | 12/09/2014 |
Decision Date | 03/04/2015 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN UPDATE TO THE LONGEVITY MANUFACTURING REQUIREMENTASSOCIATED WITH THE MODEL 102/102R AND MODEL 105 GENERATORS. |
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