Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

PAJ · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.3300

Classification

FDA Product Code: PAJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.3300
Review panel: OB
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 15

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown