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: LENS PLUS COMPACT HEAT UNIT
• Generic Name: Sterilizer, soft-lens, thermal, ac-powered
• Regulation Number: 886.5928
• Applicant: Abbott Medical Optics, Inc.; 1700 E. St. Andrew Pl.; Santa Ana, CA 92705
• PMA Number: P820082
• Supplement Number: S003
• Date Received: 02/15/1990
• Decision Date: 10/28/1991
• Product Code: HRD
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No