BLAIREX STERILE SALINE SOLUTION

FDA Premarket Approval P850045 S015

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

DeviceBLAIREX STERILE SALINE SOLUTION
Generic NameAccessories, Soft Lens Products
ApplicantBLAIREX LABORATORIES, INC.
Date Received1992-09-24
Decision Date1994-05-27
PMAP850045
SupplementS015
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BLAIREX LABORATORIES, INC. 3240 North Indianapolis Rd. p.o. Box 2127 columbus, IN 47201

Supplemental Filings

Supplement NumberDateSupplement Type
P850045Original Filing
S016 1992-09-24 Normal 180 Day Track
S015 1992-09-24 Normal 180 Day Track
S014 1989-02-10 Normal 180 Day Track
S013 1988-06-28 Normal 180 Day Track
S012
S011 1988-06-28 Normal 180 Day Track
S010 1988-02-09 Normal 180 Day Track
S009
S008 1987-10-23 Normal 180 Day Track
S007
S006 1987-09-22 Normal 180 Day Track
S005 1987-04-16 Normal 180 Day Track
S004 1987-02-19 Normal 180 Day Track
S003 1987-01-23 Normal 180 Day Track
S002 1986-11-10 Normal 180 Day Track
S001 1986-05-02 Normal 180 Day Track

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