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: CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Paco Pharmaceutical Services, Inc.; 1200 Paco Way; Bldg. 19; Lakewood, NJ 08701
• PMA Number: P850012
• Supplement Number: S004
• Date Received: 05/13/1988
• Decision Date: 08/08/1988
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No