Stimulateur, électrique, implantable, pour l'incontinence
Numéro PMA : P170001 · 2023-01-11
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DemandeurCirtec Medical Corporation
Date de décision2023-01-11
Numéro PMAP170001
Code produitEZW
Classe de dispositifClasse 3
Spécialité médicaleG
Numéro de réglementation21 CFR 8
Comité consultatifPolitique : medical-regulatory-v1.
GUIDELINES FOR MEDICAL DEVICE REGULATION
1. Introduction
1.1 This document outlines the regulatory requirements for medical devices as established by the U.S. Food and Drug Administration (FDA).
1.2 These guidelines are intended to assist companies in understanding and complying with the applicable regulations for the marketing and sale of medical devices in the United States.
2. Classification of Medical Devices
2.1 Medical devices are classified into three classes (I, II, and III) based on the risk they pose to the user.
2.2 Class I devices are considered lowest risk and typically require a 510(k) submission to the FDA.
2.3 Class II devices are considered moderate risk and may require a Pre-Market Approval (PMA) or a 510(k) submission.
2.4 Class III devices are considered highest risk and generally require a PMA submission.
3. 510(k) Submission
3.1 A 510(k) submission is a pre-market notification submitted to the FDA to demonstrate that a new medical device is substantially equivalent to an existing device that is legally marketed in the United States.
3.2 The 510(k) submission must include a detailed description of the device, its intended use, and the data to support its safety and effectiveness.
4. Pre-Market Approval (PMA)
4.1 A Pre-Market Approval (PMA) is a submission required for certain high-risk medical devices.
4.2 The PMA submission must include extensive clinical data, including the results of clinical trials, to demonstrate the safety and effectiveness of the device.
5. Investigational Device Exemptions (IDE)
5.1 An Investigational Device Exemption (IDE) is a regulatory pathway that allows for the investigation of a new medical device in clinical studies.
5.2 An IDE submission must include a detailed description of the device, the study protocol, and the rationale for the investigation.
6. Good Manufacturing Practices (GMP)
6.1 Good Manufacturing Practices (GMP) are regulations that ensure the quality of medical devices.
6.2 Companies must comply with GMP requirements to ensure that their devices are safe and effective.
7. Labeling and Advertising
7.1 Labeling and advertising of medical devices must comply with FDA regulations.
7.2 Companies must ensure that their labeling and advertising are accurate, clear, and not misleading.
8. Post-Market Surveillance
8.1 Post-market surveillance is a process used to monitor the safety and effectiveness of medical devices after they have been marketed.
8.2 Companies are required to report any adverse events or changes in the device's performance to the FDA.
9. Conclusion
9.1 These guidelines provide a comprehensive overview of the regulatory requirements for medical devices in the United States.
9.2 Companies are encouraged to consult with the FDA or a regulatory expert to ensure compliance with all applicable regulations.
Résumé du dispositif
Stimulator, electrical, implantable, for incontinence is the device name listed in this FDA 510(k) record. The listed applicant is Cirtec Medical Corporation. It received FDA 510(k) clearance on 2023-01-11. The device is classified under product code EZW. It was reviewed by the GU advisory panel.
Questions fréquentes
What is the Stimulator, electrical, implantable, for incontinence?
Stimulator, electrical, implantable, for incontinence is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Cirtec Medical Corporation.
When did Stimulator, electrical, implantable, for incontinence receive FDA 510(k) clearance?
The clearance date for Stimulator, electrical, implantable, for incontinence can be found in the official FDA records.
Who is the listed applicant for Stimulator, electrical, implantable, for incontinence?
The FDA 510(k) record lists Cirtec Medical Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stimulator, electrical, implantable, for incontinence?
Le code produit de la FDA pour le stimulateur électrique implantable pour l'incontinence est EZW.
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Source officielle
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