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Summary Basis of Decision - - Health Canada

Summary Basis of Decision (SBD) for

Summary Basis of Decision (SBD)

Summary basis of decision (SBD) documents provide information related to the original authorization of a product. The SBD for the is located below.

Updated:

The following table describes post-licensing activity for the . For more information on the type of information found in PLATs, please refer to the Frequently Asked Questions: Summary Basis of Decision (SBD) Project: Phase II.

For additional information about the medical device application process, refer to the Management of Applications for Medical Device Licences and Investigational Testing Authorizations Guidance.

Licence Number:

Post-Licensing Activity Table (PLAT)
Activity/Application Type, Application Number Date Submitted Decision and Date Summary of Activities

1 What was approved?

Application Milestones:
Application Milestone Date

For additional information about the medical device application process, refer to the Management of Applications for Medical Device Licences and Investigational Testing Authorizations Guidance.

4 What follow-up measures will the company take?

6 What other information is available about medical devices?

7 What was the scientific rationale for Health Canada's decision?

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