CHARTER LABS SALINE SOLUTION

FDA Premarket Approval P840069 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

DeviceCHARTER LABS SALINE SOLUTION
Generic NameAccessories, Soft Lens Products
ApplicantPACO PHARMACEUTICAL SERVICES, INC.
Date Received1987-08-31
Decision Date1988-04-01
PMAP840069
SupplementS004
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
P840069Original Filing
S007 1997-05-01 Normal 180 Day Track
S006 1989-09-11 Normal 180 Day Track
S005 1988-04-19 Normal 180 Day Track
S004 1987-08-31 Normal 180 Day Track
S003 1987-05-11 Normal 180 Day Track
S002 1987-05-11 30-Day Supplement
S001 1986-12-12 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.