Amendment to P890027

Containers:

Box 29 (MS 8696)

Component identifier:

File 43

Content Summary:

[Nucleus 22 channel cochlear implant system for use in children aged 2-17 years - Amendment to P890027. Contents: Table of contents./ Deficiencies./ Summary of safety and effectiveness./ Effectiveness data./ Claim 1./ Claim 2./ Claim 3./ Claim 4./ Claim 5./ Claim 6./ Claim 7./ Discussion./ Safety data./ Summary and conclusions./ Appendix A - Long-term follow-up./ Appendix B -Updated data comparison./ Appendix C - Subgroup analysis./ Appendix D - Age stratification./ Appendix E - Seminars in hearing./ Appendix F - Patient selection./ Appendix G - FDA panel minutes.] 31 August 1989

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