STERILE SALINE PRESERVED SOLUTION

FDA Premarket Approval P850070 S009

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

Elimination of ethylene oxide sterilization of the piercing cap attached to sealed 12 oz. And 16 oz. Containers of sterile preserved saline solution.

DeviceSTERILE SALINE PRESERVED SOLUTION
Generic NameAccessories, Soft Lens Products
ApplicantAUTOMATIC LIQUID PACKAGING, INC.
Date Received1997-02-14
Decision Date1997-06-20
PMAP850070
SupplementS009
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address AUTOMATIC LIQUID PACKAGING, INC. 2200 W. Lake Shore Dr. woodstock, IL 60098

Supplemental Filings

Supplement NumberDateSupplement Type
P850070Original Filing
S010 1997-06-04 Normal 180 Day Track
S009 1997-02-14 Normal 180 Day Track
S008 1995-11-03 Normal 180 Day Track
S007
S006 1990-08-28 Normal 180 Day Track
S005 1990-03-27 Normal 180 Day Track
S004 1989-10-25 Normal 180 Day Track
S003 1989-04-26 Normal 180 Day Track
S002 1987-06-17 Normal 180 Day Track
S001

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