Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: SILSOFT (ELASTOFILCON A) CONTACT LENSES
• Generic Name: Lenses, soft contact, extended wear
• Applicant: Bausch & Lomb, Inc.; 14853 DEVEAU PLACE; MINNETONKA, MN 55345
• PMA Number: P850068
• Date Received: 09/13/1985
• Decision Date: 12/31/1985
• Product Codes: HQD LPM
• Docket Number: 86M-0030
• Notice Date: 02/10/1986
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S008 S010 S011 ; S012 S014 S013