医疗器械 产品说明书 (范例).pdfVIP

INSTRUCTIONS FOR USE FOR: en English dk Dansk nl Nederlands fi Suomi fr Français de Deutsch gr Ελληνικ it Italiano no Norsk pt Português es Español se Svensk TABLE OF CONTENTS DESCRIPTION1 INTENDED.USE/INDICATIONS.FOR.USE2 CONTRAINDICATIONS2 WARNINGS2 PRECAUTIONS3 MRI.SAFETY.AND.COMPATIBILITY3 ADVERSE.EVENTS4 DEVICE.RELATED.ADVERSE.EVENT.REPORTING6 SUMMARY.OF.US.CLINICAL.STUDIES6 PRIMARY.DE NOVO.STUDY6 TIPS.REVISION.COHORT 11 HOW.SUPPLIED 13 STORAGE.AND.HANDLING 13 REQUIRED.MATERIALS 13 DIRECTIONS.FOR.USE 13 POST-PLACEMENT.MANAGEMENT.OF.THE.TIPS 15 DEFINITIONS 16 INSTRUCTIONS FOR USE GORE® VIATORR® TIPS ENDOPROSTHESIS NOTICE FOR USE WITHIN THE UNITED STATES Caution: Federal. law.(USA).restricts.this.device.to.sale.by.or.on.the.order.of.a.physician. Carefully.read.all.instructions.prior.to. use..Observe.all.warnings.and.precautions. noted.throughout.these. instructions.. Fplications. DESCRIPTION The.GORE®.VIATORR®.Transjugular. Intrahepa