STERICON SALINE SOLUTION

Accessories, Soft Lens Products

FDA Premarket Approval P850070 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

DeviceSTERICON SALINE SOLUTION
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantAUTOMATIC LIQUID PACKAGING, INC.
Date Received1989-04-26
Decision Date1989-09-18
PMAP850070
SupplementS003
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

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