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: HYVISC(R)
• Generic Name: AID, SURGICAL, VISCOELASTIC
• Regulation Number: 886.4275
• Applicant: Bausch & Lomb, Inc.; 50 Technology Dr.; Irvine, CA 92618
• PMA Number: P810025
• Supplement Number: S005
• Date Received: 11/13/1985
• Decision Date: 09/10/1987
• Product Code: LZP
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No