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: BOSTON LENS(R) CONDITIONING SOLUTION
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Polymer Technology Corp.; 1400 N Goodman St.; Rochester, NY 14692
• PMA Number: P820070
• Supplement Number: S007
• Date Received: 05/22/1984
• Decision Date: 10/10/1985
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No