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: PERFLUORON
• Generic Name: Fluid, intraocular
• Regulation Number: 886.4275
• Applicant: Alcon Laboratories; 6201 S. Fwy., R3-48; Fort Worth, TX 76134
• PMA Number: P950018
• Supplement Number: S006
• Date Received: 04/24/2001
• Decision Date: 05/15/2001
• 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  
ELIMINATION OF REDUNDANT IN PROCESS TESTING FOR %PFNO, FLUORIDE ION, NON-VOLATILE RESIDUES AND HEAVY METALS.