PMA P100014S033
- Device
- Solesta Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S033
- Product code
- LNM
- Decision date
- 2022-03-17
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Additional supplier for sodium hydroxide solution, hydrochloric acid solution and phosphate buffer concentrate.
Current openFDA PMA Record#
- Device
- Solesta Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S033
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2022-03-17
- Decision code
- OK30
- Date received
- 2022-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier for sodium hydroxide solution, hydrochloric acid solution and phosphate buffer concentrate.