REVA MEDICAL
MDR (R400) Family — Technical Documentation
Regulation (EU) 2017/745 Annex II and III
Medical Devices
FANTOM® SIROLIMUS-ELUTING BIORESORBABLE CORONARY SCAFFOLD
FANTOM® ENCORE SIROLIMUS-ELUTING BIORESORBABLE CORONARY SCAFFOLD
MOTIV® SIROLIMUS-ELUTING BIORESORBABLE VASCULAR SCAFFOLD
TF Reference: MDR (R400) Family — Technical Documentation
Volume: Vol_04 — Technical Documentation
Revision: A
Application Type: CE Marking — Class III Drug-Device Combination
Target Market: European Union
Regulatory Contact: Naomi Gong
Manufacturer
REVA Medical, LLC
5751 Copley Drive
San Diego, CA 92111
United States
CONFIDENTIAL — For Regulatory Review Purposes Only

Table of Contents

1. Title Page 1
2. Table of Contents 2
03. Cover Letter 3
3.1.1_Cover Letter 3
04. MEDICAL DEVICE COMBINATION - TECHNICAL DOCUMENTATION 4
04.Part A. Device Description and Specifications including variants and accessories 4
04.Part A.1. Device Description 4
4. Part A. 1. 1.1 — General description including product or trade names, principles of operation, mode of action etc. 4
4. Part A. 1. 2.1 — Accessories included 5
4. Part A. 1. 3.1 — Accessories not included but necessary for use 5
04.Part A.2. Intended purpose and intended users 6
4. Part A. 2. 1.1 — Intended purpose including any clinical claims 6
4. Part A. 2. 3.1 — Intended Users 7

04.Part A. Device Description and Specifications

This volume covers Annex II, Section 2 of Regulation (EU) 2017/745 — device description and specifications including all variants and accessories for the R400 product family.

04.Part A.1. Device Description

The following subsections provide the device description documentation for the R400 family of bioresorbable scaffold systems as submitted to the European regulatory authority.

4. Part A. 1. 1.1 — General description including product or trade names, principles of operation, mode of action etc.

[Content from: 4. Part A. 1. 1.1_General description including product or trade names, principles of operation, mode of action etc..pdf]
Table A.1.1 — Reference Document
Document Description Drive Link
4. Part A. 1. 1.1_General description including product or trade names, principles of operation, mode of action etc..pdf General device description, trade names, operating principles and mode of action for R400 scaffold family Open in Drive ↗

4. Part A. 1. 2.1 — Accessories included

[Content from: 4. Part A. 1. 2.1_Accessories included.pdf]
Table A.1.2 — Reference Document
Document Description Drive Link
4. Part A. 1. 2.1_Accessories included.pdf List and description of accessories included with the device Open in Drive ↗

4. Part A. 1. 3.1 — Accessories not included but necessary for use

[Content from: 4. Part A. 1. 3.1_Accessories not included but necessary for use.pdf]
Table A.1.3 — Reference Document
Document Description Drive Link
4. Part A. 1. 3.1_Accessories not included but necessary for use.pdf Accessories required for device use that are not included in the device packaging Open in Drive ↗

04.Part A.2. Intended purpose and intended users

The following subsections document the intended purpose and intended user population for the R400 family of bioresorbable scaffold systems, in accordance with Annex II, Section 2 of Regulation (EU) 2017/745.

4. Part A. 2. 1.1 — Intended purpose including any clinical claims

[Content from: 4. Part A. 2. 1.1_Intended purpose including any clinical claims.pdf]
Table A.2.1 — Reference Document
Document Description Drive Link
4. Part A. 2. 1.1_Intended purpose including any clinical claims.pdf Intended purpose statement including all clinical claims associated with the R400 scaffold family Open in Drive ↗

4. Part A. 2. 3.1 — Intended Users

[Content from: 4. Part A. 2. 3.1_Intended Users.pdf]
Table A.2.2 — Reference Document
Document Description Drive Link
4. Part A. 2. 3.1_Intended Users.pdf Description of intended users including qualifications, training and use environment Open in Drive ↗