SORBIC ACID PRESERVED LENS LUBRICANT

FDA Premarket Approval P850075 S001

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 Received1987-01-16
Decision Date1987-09-09
PMAP850075
SupplementS001
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
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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