PMA P100014S029
- Device
- Solesta Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S029
- Product code
- LNM
- Decision date
- 2020-12-11
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- a change in water source during the washing process.
Current openFDA PMA Record#
- Device
- Solesta Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S029
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2020-12-11
- Decision code
- OK30
- Date received
- 2020-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in water source during the washing process.