- Device
- Solesta Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S030
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2020-12-18
- Decision code
- OK30
- Date received
- 2020-12-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to modify the microbiological control set sampling plan in accordance with ISO 146981:2003 by replacing batch-related air sample testing to air sampling testing twice a month is acceptable