CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC

FDA Premarket Approval P850012 S004

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.

Pre-market Approval Supplement Details

• Device: CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC
• Generic Name: Accessories, Soft Lens Products
• Applicant: PACO PHARMACEUTICAL SERVICES, INC.
• Date Received: 1988-05-13
• Decision Date: 1988-08-08
• PMA: P850012
• Supplement: S004
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Special (immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: PACO PHARMACEUTICAL SERVICES, INC. 1200 Paco Way building 19 lakewood, NJ 08701

Supplemental Filings

Supplement Number	Date	Supplement Type
P850012		Original Filing
S005	1989-09-11	Normal 180 Day Track
S004	1988-05-13	Special (immediate Track)
S003	1988-04-19	Normal 180 Day Track
S002	1987-08-21	Normal 180 Day Track
S001	1987-05-11	Normal 180 Day Track