PMA P000029S080
- Device
- DEFLUX INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S080
- Product code
- LNM
- Decision date
- 2016-02-23
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Approval for modifications to Deflux labeling to reflect the findings of the post-approval study (PAS).
Current openFDA PMA Record#
- Device
- DEFLUX INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S080
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2016-02-23
- Decision code
- APPR
- Date received
- 2015-03-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for modifications to Deflux labeling to reflect the findings of the post-approval study (PAS).