Implants and Prosthetics | FDA
Products that are implanted in the body or take the place of missing body parts.
There are also consensus standards for certain active implantable 412 medical devices that include information on EMC.
Sleep Apnea Innovation SYSTEM IMPLANT MANUAL
Inspire Implantable Pulse Generator (Model 3028) Sterile Package Contents One generator One torque limiting hex wrench Product Literature (patient manual, patient registration form, patient …
1.3 Indications for Use The remedē® System is an implantable phrenic nerve stimulator indicated for the treatment of moderate to severe central sleep apnea (CSA) in adult patients.
Inspire Upper Airway Stimulation – P130008/S090 | FDA
Jul 13, 2023 · The Inspire UAS system is an implantable nerve stimulator to treat obstructive sleep apnea now indicated for use in people with greater AHI scores or greater BMI.
remedē® System – P160039 | FDA
The remedē System is an implanted nerve stimulator used to treat moderate to severe central sleep apnea (CSA) in adults.
Altius Direct Electrical Nerve Stimulation System – P230020
Sep 23, 2024 · The Altius Direct Electrical Nerve Stimulation System is an implantable device to help reduce long-term (chronic) and difficult to manage phantom limb pain and residual limb …
FDA-Approved Devices That Help Keep the Heart Beating
Implantable cardioverter defibrillators: These devices monitor heart rhythms and deliver paced heartbeats and shocks if dangerously fast rhythms are detected.
Implanted Brain-Computer Interface (BCI) Devices Considerations
May 20, 2021 · Guidance has recommendations for non-clinical testing and study design for Brain-Computer Interface (BCI) IDE feasibility and pivotal clinical studies.
List of Medical Devices , by Product Code, that FDA classifies as Implantable, Life-Saving, and Life-Sustaining Devices for purposes of Section 614 of FDASIA amending Section 519(f) of the...