NON-PRESERVED SALINE SOLUTION

FDA Premarket Approval P850025 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

DeviceNON-PRESERVED SALINE SOLUTION
Generic NameAccessories, Soft Lens Products
ApplicantPACO PHARMACEUTICAL SERVICES, INC.
Date Received1987-05-11
Decision Date1987-10-07
PMAP850025
SupplementS003
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
P850025Original Filing
S007 1989-02-17 Normal 180 Day Track
S006 1988-05-13 Special (immediate Track)
S005 1988-04-19 Normal 180 Day Track
S004 1987-11-04 Normal 180 Day Track
S003 1987-05-11 Normal 180 Day Track
S002 1986-12-31 Normal 180 Day Track
S001 1986-08-26 Normal 180 Day Track

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