Device Access Education | MemoryGel™ Implant PAS | Labeling | Forms
Single PDF file containing: Introductory Letter, Adjunct Study Information, Training Information, Physician Tracking Requirements, and the MemoryGel™ Breast Implant Device Tracking Form. Please see below for individual letters and components.
Individual Letters & Attachments Downloads
Important MemoryGel™ Implant Introductory Information
Important Adjunct Study Information
Important Training Information
A review of some of the important aspects specific to the Adjunct study, and templates you can use to communicate these important changes with your local IRB and Adjunct patients, who need to understand their continuing obligation to the Adjunct study.
This Approval Letter for Mentor's MemoryGel™ Breast Implants links to the officially archived approval letter on the U.S. Food & Drug Administration's website.
Post-Approval Study Process Flow Chart:
MemogyGel™Implant ParticipantsDownload as PDF
Post-Approval Study Process Flow Chart:
Saline Control ChartDownload as PDF
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