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 | NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S011 |
Date Received | 10/01/1998 |
Decision Date | 10/16/1998 |
Product Code |
LYJ |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement The 30-day Notice requested that a welding process be added to the firms' internal manufacturing capabilities. This process is equivalent to the welding process already performed by Cyberonics' subcontractors. The process is being brougth in-house in order to simplify the manufacturing process, improve control of product flow, and improve product availability. |
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