PMA P250051
- Device
- Juveena Hydrogel System
- Applicant
- Rejoni, Inc.
- PMA number
- P250051
- Product code
- MCN
- Decision date
- 2026-09-28
- Classification
- Obstetrics/Gynecology
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- Approval for Juveena® Hydrogel System. The Juveena® Hydrogel System is indicated for use in adult women to reduce the incidence and severity of intrauterine adhesion formation following hysteroscopic adhesiolysis for symptomatic moderate to severe intrauterine adhesions.The Rejoni Acorn Catheter is indicated to access the uterine cavity and deliver the Juveena® Hydrogel solution into the uterine cavity.
Current openFDA PMA Record#
- Device
- Juveena Hydrogel System
- Applicant
- Rejoni, Inc.
- PMA number
- P250051
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2026-09-28
- Decision code
- APPR
- Date received
- 2025-12-10
- Approval order statement
- Approval for Juveena® Hydrogel System. The Juveena® Hydrogel System is indicated for use in adult women to reduce the incidence and severity of intrauterine adhesion formation following hysteroscopic adhesiolysis for symptomatic moderate to severe intrauterine adhesions.The Rejoni Acorn Catheter is indicated to access the uterine cavity and deliver the Juveena® Hydrogel solution into the uterine cavity.