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: OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Alcon Laboratories; R; Van Nuys, CA 30348
• PMA Number: P830034
• Supplement Number: S027
• Date Received: 05/12/1995
• Decision Date: 09/26/1995
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL TO MODIFY THE LABELING FOR THE OPTI-ONE MULTI-PURPOSE SOLUTION BY EXPANDING THE APPROVAL FOR INDICATIONS FOR USE