Information about Proposition 65 for California customers
California’s Proposition 65, The Safe Drinking Water and Toxic Enforcement Act, as amended, requires businesses to inform individuals of potential exposure to certain chemicals identified by the State of California that may cause cancer, birth defects or reproductive effects.
Enterra Medical has identified its products that are in scope of Proposition 65 disclosure requirements. Please review the table below for a list of affected products. Enterra Medical considers patient safety and customer satisfaction its top priorities. View Terms of Use.
Enterra® Therapy System
| Product name / model number | Product description |  Prop 65 warning |
|---|---|---|
| Enterra 37800 | Neurostimulator |  WARNING: This product can expose you to chemicals including Ethylene Oxide which is known to the State of California to cause cancer and/or birth defects and other reproductive harm.For more information, go to www.P65Warnings.ca.gov |
| Enterra Lead 4351 | Unipolar lead | WARNING: This product can expose you to chemicals including Ethylene Oxide which is known to the State of California to cause cancer and/or birth defects and other reproductive harm. For more information, go to www.P65Warnings.ca.gov |
MKT-D-0003, Rev X
IMPORTANT SAFETY INFORMATION
Enterra Therapy for treatment of chronic, resistant to medication nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years: patients should always discuss potential risks and benefits of the device with their physician.
*HUMANITARIAN DEVICE
Authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated. What does this mean?