CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC

FDA Premarket Approval P850012 S003

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

DeviceCHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC
Generic NameAccessories, Soft Lens Products
ApplicantPACO PHARMACEUTICAL SERVICES, INC.
Date Received1988-04-19
Decision Date1988-07-29
PMAP850012
SupplementS003
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address PACO PHARMACEUTICAL SERVICES, INC. 1200 Paco Way building 19 lakewood, NJ 08701

Supplemental Filings

Supplement NumberDateSupplement Type
P850012Original 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

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