植入物，听力，主动，中耳，完全植入
PMA编号：P090018 · 2026-06-03
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决定日期2026-06-03
PMA 编号P090018
产品代码OAF
设备分类第3类
医疗专科U
咨询委员会医疗设备监管文本描述翻译如下：
关于[公司/产品名称]的监管信息：
- 美国食品药品监督管理局（FDA）批准号：[510(k)编号]
- 预市场批准（PMA）申请号：[PMA编号]
- 临床试验注册号（NCT）：[NCT编号]
- 医学文献标识符（PMID）：[PMID编号]
- 产品标识符：[标识符]
- 相关政策：医疗监管政策v1
- 更多信息请访问：[URL]
请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。
器械摘要
Implant, hearing, active, middle ear, totally implanted is the device name listed in this FDA 510(k) record. The listed applicant is Envoy Medical Corporation. It received FDA 510(k) clearance on 2026-06-03. The device is classified under product code OAF. It was reviewed by the EN advisory panel.
常见问题
What is the Implant, hearing, active, middle ear, totally implanted?
Implant, hearing, active, middle ear, totally implanted is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Envoy Medical Corporation.
When did Implant, hearing, active, middle ear, totally implanted receive FDA 510(k) clearance?
The clearance date for Implant, hearing, active, middle ear, totally implanted can be found in the official FDA records.
Who is the listed applicant for Implant, hearing, active, middle ear, totally implanted?
The FDA 510(k) record lists Envoy Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Implant, hearing, active, middle ear, totally implanted?
The FDA product code for Implant, hearing, active, middle ear, totally implanted is OAF.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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