MIRAFLOW EXTRA STRENGTH CLEANER

Accessories, Soft Lens Products

FDA Premarket Approval P850055 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

DeviceMIRAFLOW EXTRA STRENGTH CLEANER
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantCIBA VISION CORPORATION
Date Received1989-04-17
Decision Date1989-09-14
PMAP850055
SupplementS003
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
P850055Original Filing
S009 1990-11-01 Normal 180 Day Track
S008
S007
S006 1990-05-09 Normal 180 Day Track
S005
S004 1990-02-20 Normal 180 Day Track
S003 1989-04-17 Normal 180 Day Track
S002 1988-03-03 Normal 180 Day Track
S001 1987-06-11 30-Day Supplement

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