NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator
FDA premarket approval P970003/S206 · decided 2016-12-06
Approval details
- PMA number
- P970003
- Supplement
- S206
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NCP Model 201 Programming Wand, VNS Therapy AspireHC Model 105 Generator, VNS Therapy AspireSR, Model 106 Generator
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2016-11-07
- Decision date
- 2016-12-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- The following four (4) changes being made to the surface mounting technology (SMT) processes associated with the Model 201 Programming Wand and the Model 105/106 Generator: 1) Introduction of a New Heller Reflow Oven*; 2) New No Clean (NC) solder paste with Improved Solder Coalescence Properties*; 3) Removal of Silkscreen PCBA Labeling (Model 105/106 Only); and 4) Addition of a Block Skip Function to SMT Pick & Place Software (Model 105/106 Only).
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