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: ADAPPTE ARTIFICIAL TEAR
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Alcon Laboratories; P.O. Box 289 4218 Howard Ave.; Kensington, MD 20795
• PMA Number: N16993
• Supplement Number: S004
• Date Received: 05/05/1980
• Decision Date: 06/04/1980
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No