EZY — Device, Incontinence, Mechanical/Hydraulic Class III
FDA product code EZY covers "Device, Incontinence, Mechanical/Hydraulic", a Class III medical device regulated under 21 CFR 876.5280. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants.
Classification Details
- Product Code
- EZY
- Device Class
- Class III
- Regulation Number
- 876.5280
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))