SORBIC ACID PRESERVED LENS LUBRICANT

FDA Premarket Approval P850075 S006

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

DeviceSORBIC ACID PRESERVED LENS LUBRICANT
Generic NameAccessories, Soft Lens Products
ApplicantPACO PHARMACEUTICAL SERVICES, INC.
Date Received1989-09-06
Decision Date1990-04-12
PMAP850075
SupplementS006
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address PACO PHARMACEUTICAL SERVICES, INC. 1200 Paco Way building 19 lakewood, NJ 08701

Supplemental Filings

Supplement NumberDateSupplement Type
P850075Original Filing
S009 1997-05-01 Normal 180 Day Track
S008 1990-06-20 Normal 180 Day Track
S007 1989-09-11 Normal 180 Day Track
S006 1989-09-06 Normal 180 Day Track
S005 1988-05-13 Special (immediate Track)
S004 1988-04-19 Normal 180 Day Track
S003 1987-08-05 Normal 180 Day Track
S002 1987-05-11 Normal 180 Day Track
S001 1987-01-16 Normal 180 Day Track

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