Device Labeling

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Philip Goodwin
5 years ago
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1 Device Labeling This section displays the proposed device labels for the XIENCE Xpedition 1 SV, XIENCE Xpedition, and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System. Representative product labels provided in Module 1 have been updated in this Module to represent the compliance chart data and a correction to the address for the Authorized Representative. Additionally, the IFU (provided in Module 1) will be translated and offered in multiple languages. 7.1 Proposed Product Labels (compliance charts, header bag label, carton/pouch labels) for XIENCE Xpedition SV, XIENCE Xpedition, XIENCE Xpedition LL 7.2 Generic Packaging Pieces (pre-printed header bag, pre-printed foil pouch) 7.3 Pre-Printed Cartons 7.4 Proposed Instructions for Use (provided in Module 1) The XIENCE Xpedition Everolimus Eluting Stent System (XIENCE Xpedition Stent System) is packaged with the respective product label. The same label is used for the foil pouch and the cartons. The finished product, with compliance chart (Section 7.1), is placed inside a header bag (Section 7.2). The header bag label (Section 7.1) is then applied. Each labeled header bag is placed inside a foil pouch (Section 7.2). A carton/pouch label (Section 7.1) is applied to the foil pouch and sealed. The sealed, labeled foil pouch is then placed inside an individual carton (Section 7.3), along with the Instructions for Use (Module 1). The carton/pouch label (Section 7.1) is then applied to the outside carton. 1 During the course of development, XIENCE Xpedition was also referred to as RACER. XIENCE Xpedition SV, XIENCE Xpedition and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System are the final commercial names for this product, and are dependent on the stent length and diameter. Hereinafter, XIENCE Xpedition SV, XIENCE Xpedition and XIENCE Xpedition LL Everolimus Eluting Coronary Stent and Everolimus Eluting Coronary Stent System will be referred to as the XIENCE Xpedition stent or XIENCE Xpedition Stent System, respectively.

7.0-2 7.1 Proposed Product Labels XIENCE Xpedition SV Stent System Product labels are fixed on chipboard box, foil pouch and sterile barrier pre-printed header bag.

2 Proposed Product Labels XIENCE Xpedition SV Stent System Product labels are fixed on chipboard box, foil pouch and sterile barrier pre-printed header bag. The top portion of the label folds over the box so the system size can be easily identified from the back and spine of the box. There is a Compliance Chart Card inside every sterile barrier with the finished product. Figure 7-1 Representative Balloon Compliance Chart for the XIENCE Xpedition SV Stent System mm diameter

3 7.0-3 Figure 7-2 Representative Header Bag Label for the XIENCE Xpedition SV Stent System mm x 8 mm

4 7.0-4 Figure 7-3 Representative Carton and Foil Pouch Label for the XIENCE Xpedition SV Stent System mm x 8 mm

5 7.0-5 Proposed Product Labels XIENCE Xpedition Stent System Figure 7-4 Representative Balloon Compliance Chart for the XIENCE Xpedition Stent System mm diameter

6 7.0-6 Figure 7-5 Representative Header Bag Label for the XIENCE Xpedition Stent System mm x 12 mm

7 7.0-7 Figure 7-6 Representative Carton and Foil Pouch Label for the XIENCE Xpedition Stent System 3.0 mm x 12 mm

8 7.0-8 Proposed Product Labels XIENCE Xpedition LL Stent System Figure 7-7 Representative Balloon Compliance Chart for the XIENCE Xpedition LL Stent System 3.25 mm diameter

9 7.0-9 Figure 7-8 Representative Header Bag Label for the XIENCE Xpedition LL Stent System 3.25 mm x 38 mm

7.0-10 Figure 7-9 Representative Carton and Foil Pouch

10 Figure 7-9 Representative Carton and Foil Pouch Label for the XIENCE Xpedition LL Stent System 3.25 mm x 38 mm

11 Generic Packaging Pieces Figure 7-10 Representative Proposed Pre-Printed Header Bag (Sterile Barrier)

12 Figure 7-11 Representative Proposed Pre-Printed Foil Pouch - Printed 1-Sided THIS IS NOT A STERILE BARRIER in 25 Languages

13 Figure 7-12 Representative Foil Pouch Non-Sterile Barrier Label

14 Pre-Printed Cartons In the following pages you will find representative pictures of what the Pre-Printed Generic Cartons will look like for each product name.

15 Figure 7-13 Pre-Printed Generic Carton for the XIENCE Xpedition SV Stent System (Temecula, CA)

16 7.0-16

7.0-17 Figure 7-14 Pre-Printed Generic Carton for

17 Figure 7-14 Pre-Printed Generic Carton for the XIENCE Xpedition Stent System (Clonmel, Ireland)

18 7.0-18

19 Figure 7-15 Pre-Printed Generic Carton for the XIENCE Xpedition Stent System (Temecula, CA)

20 7.0-20

21 Figure 7-16 Pre-Printed Generic Carton for the XIENCE Xpedition Stent System (Clonmel, Ireland)

22 7.0-22

23 Figure 7-17 Pre-Printed Generic Carton for the XIENCE Xpedition LL Stent System (Temecula, CA)

24 7.0-24

25 Figure 7-18 Pre-Printed Generic Carton for the XIENCE Xpedition LL Stent System (Clonmel, Ireland)

26 7.0-26

27 Proposed Instructions for Use for the XIENCE Xpedition, XIENCE Xpedition SV, XIENCE Xpedition LL Everolimus Eluting Coronary Stent System The Instructions for Use booklet will be placed inside the box alongside the XIENCE Xpedition Stent System. A sample copy of the proposed Instructions for Use booklet was included in Module 1.

The Xience V Stent Pipeline

The Xience V Stent Pipeline Optimal Balance of Stent t Performance and Safety Chuck Simonton MD, FACC, FSCAI Chief Medical Officer Abbott Vascular Santa Clara, CA USA DES Summit TCT-AP Seoul, Korea 2013