Declaration Of Conformity - Medtronic RestoreULTRA 37712 Manual De Instrucciones

Filename Date Time
UC200xxxxxx EN
4.625 x 6 inches (117 mm x 152 mm)
Table 3. Material of components in the Model 37712 RestoreULTRA package
Components
Neurostimulator
Case
Connector block
Grommets, seals
Setscrews
Adhesive
Torque wrench
Handle
Shaft

Declaration of conformity

Medtronic declares that this product is in conformity with the essential requirements of Directive
1999/5/EC on Radio and Telecommunications Terminal Equipment and Directive 90/385/EEC
on Active Implantable Medical Devices.
For additional information, contact the appropriate Medtronic representative listed on the inside
back cover of this manual.
8 English 37712
2007-9
Material
Titanium
Polysulfone, silicone rubber,
silicone medical adhesive
Silicone rubber
Titanium alloy
Silicone medical adhesive
Ultem
Stainless steel
M927169A004
Medtronic Confidential
IPGTemplate.fm
Version: 10-23-2007
Material contacts
human tissue
Yes
Yes
Yes
Yes
Yes
Yes
Yes