|
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 | S017 |
Date Received | 01/04/1999 |
Decision Date | 01/28/1999 |
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 to bring in-house a seam welding process equivalent to processes performed by subcontractors. The welding process involves welding the can bottom half of the Pulse Generator to a can lid. |