PMA P100014S035
- Device
- Solesta® Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S035
- Product code
- LNM
- Decision date
- 2023-12-07
- Classification
- Gastroenterology, Urology
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- modification of the Water for Injection (WFI) distributor system
Current openFDA PMA Record#
- Device
- Solesta® Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S035
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2023-12-07
- Decision code
- OK30
- Date received
- 2023-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modification of the Water for Injection (WFI) distributor system