CIBA VISION LENS DROPS

FDA Premarket Approval P860060 S002

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

DeviceCIBA VISION LENS DROPS
Generic NameAccessories, Soft Lens Products
ApplicantCIBA VISION CARE
Date Received1989-08-21
Decision Date1990-03-28
PMAP860060
SupplementS002
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 CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518

Supplemental Filings

Supplement NumberDateSupplement Type
P860060Original Filing
S002 1989-08-21 Normal 180 Day Track
S001 1988-05-06 Normal 180 Day Track

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