PAJ — Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed Class II
FDA product code PAJ covers "Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PAJ
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- OB
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.