JCW — Prosthesis, Penis, Inflatable Class III
FDA product code JCW covers "Prosthesis, Penis, Inflatable", a Class III medical device regulated under 21 CFR 876.3350. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants.
Classification Details
- Product Code
- JCW
- Device Class
- Class III
- Regulation Number
- 876.3350
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))