PMA P910071S018
- Device
- ADATO Sil-Ol 5000 Silicone Oil
- Applicant
- Bausch & Lomb
- PMA number
- P910071
- Supplement
- S018
- Product code
- LWL
- Decision date
- 2021-12-02
- Generic name
- Fluid, intraocular
- Approval order statement
- Update the dry heat sterilization equipment for ADATO® SIL-OL 5000 prefilled syringe.
Current openFDA PMA Record#
- Device
- ADATO Sil-Ol 5000 Silicone Oil
- Applicant
- Bausch & Lomb
- PMA number
- P910071
- Supplement
- S018
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2021-12-02
- Decision code
- OK30
- Date received
- 2021-11-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the dry heat sterilization equipment for ADATO® SIL-OL 5000 prefilled syringe.