PMA P910071S019

Device
ADATO SIL-OL 5000 Silicone Oils
Applicant
Bausch & Lomb
PMA number
P910071
Supplement
S019
Product code
LWL
Decision date
2025-12-22
Classification
Ophthalmic
Generic name
Fluid, intraocular
Approval order statement
approval of the addition of a new autoclave (ID1097) for ADATO SIL-OL 5000 Silicone Oils

Current openFDA PMA Record#

Device
ADATO SIL-OL 5000 Silicone Oils
Applicant
Bausch & Lomb
PMA number
P910071
Supplement
S019
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2025-12-22
Decision code
OK30
Date received
2025-11-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval of the addition of a new autoclave (ID1097) for ADATO SIL-OL 5000 Silicone Oils