PMA P000029S085
- Device
- Deflux Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S085
- Product code
- LNM
- Decision date
- 2019-08-29
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Replacement of a wall section with a door in the 3:125B clean room at the Q-Med manufacturing site.
Current openFDA PMA Record#
- Device
- Deflux Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S085
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2019-08-29
- Decision code
- OK30
- Date received
- 2019-08-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of a wall section with a door in the 3:125B clean room at the Q-Med manufacturing site.