PMA P000029S088
- Device
- DEFLUX Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S088
- Product code
- LNM
- Decision date
- 2020-02-27
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Use a resistometer in the D-value determination for Biological Indicators.
Current openFDA PMA Record#
- Device
- DEFLUX Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S088
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2020-02-27
- Decision code
- OK30
- Date received
- 2020-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use a resistometer in the D-value determination for Biological Indicators.