PMA P910071S013
- Device
- ADATO SIL-OL 5000 SILICONE OIL
- Applicant
- Bausch & Lomb
- PMA number
- P910071
- Supplement
- S013
- Product code
- LWL
- Decision date
- 2012-01-24
- Generic name
- Fluid, intraocular
- Approval order statement
- APPROVAL FOR THE ADDITION OF A HEAT SHRINK TUBE TO THE PRIMARY PACKAGING FOR THE DEVICE TO ASSURE A TIGHTER FIT BETWEEN THE LUER ADAPTER AND THE SYRINGE BARREL BODY.
Current openFDA PMA Record#
- Device
- ADATO SIL-OL 5000 SILICONE OIL
- Applicant
- Bausch & Lomb
- PMA number
- P910071
- Supplement
- S013
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2012-01-24
- Decision code
- APPR
- Date received
- 2010-12-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF A HEAT SHRINK TUBE TO THE PRIMARY PACKAGING FOR THE DEVICE TO ASSURE A TIGHTER FIT BETWEEN THE LUER ADAPTER AND THE SYRINGE BARREL BODY.