MemoryGel™ Implant Physician Correspondence & Forms

Introduction to MemoryGel™ Implant Packet – Click to Download All Letters & Attachments

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

Physician Tracking Requirements

Device Tracking Form

Adjunct Study Follow-up Letter with IRB/Patient Templates

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.

FDA Approval Letter For MemoryGel™ Implants

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.

 

MemoryGel™ Breast Implant Post-Approval Study (PAS) Enrollment Information

Please see the following charts for follow-requirements for the Mentor Post Approval Study (PAS). To enroll, please request a copy of the PAS protocol from your Mentor Sales or Clinical Representative. The protocol explains everything you need to know about the study and has samples of the patient follow-up forms. For additional information, please visit our Frequently Asked Questions (FAQs) area.

Post-Approval Study Process Flow Chart: MemogyGel™Implant Participants Download as PDF	Post-Approval Study Process Flow Chart: Saline Control Chart Download as PDF

 

 

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