Additional Symbols For Product Labels; Appendix E: Ce Mark Date - St.Jude Medical Proclaim Manuel

Générateur d'impulsions implantable (gii)
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Symbol
Description
European conformity, affixed in accordance with the relevant provisions of AIMD
directive 90/385/EEC and R&TTE directive 1999/5/EC. Hereby, St. Jude Medical
declares that this device is in compliance with the essential requirements and other
relevant provisions of these directives.
Australian Communications and Media Authority (ACMA) and New Zealand Radio
Spectrum Management (RSM) Regulatory Compliance Mark (RCM)
New Zealand Radio Spectrum Management (RSM) compliance mark for products
that have radio transmitters of conformity level A1, A2, or A3
This equipment is certified for type certification pursuant of Article 38-24 of the
Japan Radio Law

Additional Symbols for Product Labels

Symbol

Appendix E: CE Mark Date

The following table lists the year in which the CE mark was awarded from the applicable notified
body by model number.
Table 7. Year in which CE mark was awarded
Model
1101
1111
3660, 3662, 3665, 3667
ARTMT100145789A.pdf 20
Description
Torque wrench
Port plug
Implantable pulse generator
Year
1999
2006
2015
18
Notified Body
0123
0123
0086
11/11/2015 8:52:58 AM

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