PMA P250051S001
- Device
- Juveena Hydrogel System
- Applicant
- Rejoni, Inc.
- PMA number
- P250051
- Supplement
- S001
- Product code
- MCN
- Decision date
- 2026-10-28
- Classification
- Obstetrics/Gynecology
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- a change to remove visible particulates prior to final packaging
Current openFDA PMA Record#
- Device
- Juveena Hydrogel System
- Applicant
- Rejoni, Inc.
- PMA number
- P250051
- Supplement
- S001
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2026-10-28
- Decision code
- OK30
- Date received
- 2026-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to remove visible particulates prior to final packaging