PMA P000029S075
- Device
- DEFLUX INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S075
- Product code
- LNM
- Decision date
- 2013-10-17
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR LABELING CHANGES, WHICH ADD TWO ADDITIONAL TECHNIQUES FOR INJECTION, THE HIT AND DOUBLE-HIT.
Current openFDA PMA Record#
- Device
- DEFLUX INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S075
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2013-10-17
- Decision code
- APPR
- Date received
- 2013-07-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES, WHICH ADD TWO ADDITIONAL TECHNIQUES FOR INJECTION, THE HIT AND DOUBLE-HIT.