- Device
- Deflux Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S083
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2018-11-08
- Decision code
- APPR
- Date received
- 2018-04-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for change in the manufacturer of Teflon part of equipment used during manufacturing of the Deflux and Solesta Injectable Gel.