Premarket Approval (PMA)

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.

• Device: Silikon 1000
• Generic Name: Fluid, intraocular
• Regulation Number: 886.4275
• Applicant: Alcon; 6201 S. Fwy.; Mail Drop R7-14; Fort Worth, TX 76134
• PMA Number: P950008
• Supplement Number: S022
• Date Received: 09/08/2023
• Decision Date: 10/20/2023
• Product Code: LWL
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Change to add an alternate sterilization cycle for items used in the filling operation of the Silikon 1000 product.