PMA P850088S036

Device: ULTRA CARE (TM) NEUTRALIZING TABLET
Applicant: Advanced Medical Optics, Inc.
PMA number: P850088
Supplement: S036
Product code: LPN
Decision date: 1997-07-03
Generic name: Accessories, soft lens products
Approval order statement: APPROVAL FOR AN ALTERNATE FORMULATION USING CATALASE RAW MATERIAL DERIVED FROM A NON-ANIMAL SOURCE AND AN ASSOCIATED CHANGE IN THE MINIMUM NEUTRALIZATION SOAK TIME FROM 2 TO 4 HOURS. THE ALTERNATE FORMULATION INCLUDES NO CHANGES IN THE INDICATIONS FOR USE.

Current openFDA PMA Record#

Device: ULTRA CARE (TM) NEUTRALIZING TABLET
Applicant: Advanced Medical Optics, Inc.
PMA number: P850088
Supplement: S036
Product code: LPN
Generic name: Accessories, soft lens products
Decision date: 1997-07-03
Decision code: APPR
Date received: 1996-08-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN ALTERNATE FORMULATION USING CATALASE RAW MATERIAL DERIVED FROM A NON-ANIMAL SOURCE AND AN ASSOCIATED CHANGE IN THE MINIMUM NEUTRALIZATION SOAK TIME FROM 2 TO 4 HOURS. THE ALTERNATE FORMULATION INCLUDES NO CHANGES IN THE INDICATIONS FOR USE.