PMA P000029S078
- Device
- DEFLUX INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S078
- Product code
- LNM
- Decision date
- 2014-07-31
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- QUALIFY AN ALTERNATE SUPPLIER OF THE READY-PREPARED SOLUTIONS OF NAOH AND HCL USED FOR THE MANUFACTURING OF DEFLUX DEVICE.
Current openFDA PMA Record#
- Device
- DEFLUX INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P000029
- Supplement
- S078
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2014-07-31
- Decision code
- OK30
- Date received
- 2014-07-03
- Supplement type
- 30-Day Notice
- Approval order statement
- QUALIFY AN ALTERNATE SUPPLIER OF THE READY-PREPARED SOLUTIONS OF NAOH AND HCL USED FOR THE MANUFACTURING OF DEFLUX DEVICE.