Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System
NCT: NCT04770870 · ACTIVE_NOT_RECRUITING
Brief Summary
The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post-Approval Study Report per the requirements set forth in the approval.
Frequently Asked Questions
What is Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System?
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System is a clinical trial registered under NCT04770870. Current status: ACTIVE_NOT_RECRUITING.
What is the status of NCT04770870?
The current status of NCT04770870 (Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System) is: ACTIVE_NOT_RECRUITING.
When did Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System start?
Post Approval Study2: Hintermann Series H3 Total Ankle Replacement System started on 2022-02-01.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.