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 | S214 |
Date Received | 11/20/2017 |
Decision Date | 12/27/2017 |
Product Codes |
LYJ MUZ |
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 Change to the Leads Manufacturing Process to add the following two (2) processes on all commercially available Lead Models (302/303/304):1) Additional use of the currently approved primer; proposed application to the Suture and along the exposed edge of the Electrode; and2) Implementation of a Protection Aid to encapsulate the Lead Helicals, protecting them from Ribbon Damage during further processing steps. This will be removed at the end of the Lead Final assembly. |
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