MAUDE
notableCitations
Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that since they started having bronchitis in (b)(6) of this year, their therapy wouldn't let them go past 1.3 mA. The patient attempt
Penetration testing, SBOM, threat modeling, and 524B submission support for MedTech.