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: LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
• Generic Name: Catheter, balloon for retinal reattachment
• Applicant: Bausch & Lomb; 50 Technology Dr.; Irvine, CA 92618
• PMA Number: P820009
• Supplement Number: S001
• Date Received: 06/27/1985
• Decision Date: 09/05/1985
• Withdrawal Date: 01/23/2015
• Product Code: LOG
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No