APPLIED LABORATORIES STERILE SALINE SOLUTION

Accessories, Soft Lens Products

FDA Premarket Approval P870002 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

DeviceAPPLIED LABORATORIES STERILE SALINE SOLUTION
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantAPPLIED LABORATORIES, INC.
Date Received1989-02-23
Decision Date1989-04-05
PMAP870002
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 APPLIED LABORATORIES, INC. 3240 North Indianapolis Rd. p.o. Box 448 columbus, IN 47201

Supplemental Filings

Supplement NumberDateSupplement Type
P870002Original Filing
S012 1992-09-23 Normal 180 Day Track
S011 1992-04-15 Normal 180 Day Track
S010 1992-03-09 Normal 180 Day Track
S009 1990-08-28 Normal 180 Day Track
S008
S007
S006 1989-08-24 Normal 180 Day Track
S005 1989-08-01 Normal 180 Day Track
S004 1989-02-23 Normal 180 Day Track
S003 1988-07-25 30-Day Supplement
S002 1988-04-22 Normal 180 Day Track
S001 1988-01-27 Normal 180 Day Track

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