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: S019
• Date Received: 05/22/2023
• Decision Date: 09/15/2023
• Product Code: LWL
• Advisory Committee: Ophthalmic
• Supplement Type: 135 Review Track For 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  
Approval for an additional alternate sterilizer for the in-house dry heat sterilization of the Silikon 1000 product.