Стенты и системы для стентирования: cтенты билиарные WallFlex™ / WallFlex™ Biliary Stent Systems

Pays: Biélorussie

Langue: russe

Source: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Disponible depuis:

Boston Scientific Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

classe:

изделия медицинского назначения

Fabriqué par:

Boston Scientific Corporation

Date de l'autorisation:

2016-11-01

Résumé des caractéristiques du produit

INSTRUCCIONES DE USO
10
MODE D’EMPLOI
19
GEBRAUCHSANWEISUNG
29
ISTRUZIONI PER L’USO
39
GEBRUIKSAANWIJZING
48
INSTRUÇÕES DE UTILIZAÇÃO
57
Boston Scientific (Master Brand DFU Template 8in x 8in Global,
90106041AK), DFU, MB, Carotid WALLSTENT, Global, 90965510-01A
DIRECTIONS FOR USE
2
CAROTID WALLSTENT
™
Closed Cell Self-Expanding Stent
m o n o r a i l ™ E n d o p r o s t h E s i s
2
Boston Scientific (Master Brand DFU Template 8in x 8in Global,
90106041AK), DFU, MB, Carotid WALLSTENT, Global, 90965510-01A
WARNING
............................................................................................................................3
1. DEVICE DESCRIPTION
..................................................................................................3
Figure 1. Carotid WALLSTENT™ Monorail™ Endoprosthesis
...........................3
Table 1. Carotid WALLSTENT Monorail Endoprosthesis
(0.014 in / 0.36 mm Guidewire Lumen) Stent Sizes and Sizing
...........................3
1.1 Contents
...................................................................................................................4
2. INTENDED USE/INDICATIONS FOR USE
...................................................................4
3.
CONTRAINDICATIONS..................................................................................................4
4. WARNINGS
.....................................................................................................................4
4.1 General Warnings
....................................................................................................4
4.2 Patient Selection
......................................................................................................4
4.2.1 Patient Characteristics
........................................................................................4
4.2.2 Lesion Characteristics
.........................................................................................4
4.2.3 Access Characteristics
........................................