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: H55 HYDROPHILIC CONTACT LENS
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: THE COOPER COMPANIES; 6150 Stoneridge Mall Road; Suite 370; Pleasanton, CA 94588
• PMA Number: P890023
• Date Received: 04/03/1989
• Decision Date: 09/19/1989
• Product Code: LPM
• Docket Number: 89M-0472
• Notice Date: 11/27/1989
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S025 S015 ; S016 S019 S022 S011 S014 S024 S026 S023 S018 S020 S021 S013 ; S017 S027 S042 S043 S044 S045 S033 S034 S028 S032 S035 S031 ; S030 S029 S038 S036 S037 S039 S046 S047 S040 S049 S048