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SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I.GENERAL INFORMATION Device Generic Name: Replacement Heart Valve Device Trade Name: ATS 3f Aortic Bioprosthesis, Model 1000 (sizes 21, 23, 25, 27, and 29mm) Applicant\'s Name and Address:ATS Medical, Inc. 20412 James Bay Circle Lake Forest, CA 92630Date of Panel Recommendation: none Premarket Approval Application (PMA) Number: P060025 Date of FDA Notice of Approval: October 30, 2008 Expedited: not applicable II.INDICATIONS FOR USE The ATS
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How to fill out device generic name replacement

01
Identify the device for which the generic name is being replaced.
02
Gather all necessary documentation related to the device.
03
Look up the standard generic name for the device type in the appropriate resources.
04
Fill in the required forms with the standard generic name.
05
Double-check for accuracy to ensure compliance with relevant regulations.
06
Submit the forms to the appropriate regulatory body or organization.

Who needs device generic name replacement?

01
Manufacturers of medical devices looking to comply with regulatory standards.
02
Healthcare providers who need to report or document device names for inventory or patient records.
03
Regulatory authorities that require accurate documentation of medical devices for safety and tracking.
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Device generic name replacement refers to the process of updating or changing the generic name assigned to a medical device for regulatory or classification purposes.
Manufacturers of medical devices or their authorized representatives are typically required to file for device generic name replacement.
To fill out a device generic name replacement, one should complete the designated form provided by the regulatory authority, ensuring to include device identification details, the reason for replacement, and other required supporting documentation.
The purpose of device generic name replacement is to ensure accurate and updated classification of medical devices, facilitating better regulation, marketing, and usage of the devices in healthcare.
Information that must be reported includes the current generic name, the proposed new generic name, justification for the change, device identification information, and any relevant supporting documentation.
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