BLAIREX STERILE SALINE SOLUTION

Accessories, Soft Lens Products

FDA Premarket Approval P850045 S011

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
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantBLAIREX LABORATORIES, INC.
Date Received1988-06-28
Decision Date1989-05-02
PMAP850045
SupplementS011
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
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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