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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceADATO SIL-OL 5000 Silicone Oils
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantBausch & Lomb
50 Technology Dr.
Irvine, CA 92618
PMA NumberP910071
Supplement NumberS019
Date Received11/26/2025
Decision Date12/22/2025
Product Code LWL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the addition of a new autoclave (ID1097) for ADATO SIL-OL 5000 Silicone Oils
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