Implantable Device
Found 3 free book(s)
Medical device patient information leaflets and implant cards
www.tga.gov.auimplantable medical device. means a medical device (other than an active implantable medical device) that is intended by the manufactu rer: (a) to be, by surgical intervention, wholly introduced into the body of a human being, and to remain in place after the procedure; or
Medical Device Directive (MDD)
www.medicaldevicesgroup.netThere are four device classifications: – Class I – Class IIa – Class IIb – Class III. Class I devices, that are non- sterile and non-measuring, do not require a Notified Body (NB). All other products require NB involvement. Annex IX of the MDD defines the classification rules for Europe. There is also a guidance document, MEDDEV 2.4/1
CMS Manual System
www.cms.gov3. Device Pass-Through Category Codes. Effective January 1, 2022, the complete list of device pass-through category codes and the explanations of certain terms/definitions related to these device category codes can be found in section 60.4 (General Coding and Billing Instructions and Explanations) of Chapter 4 of the Medicare Claims Processing ...