CUSTOMEYES 70L & 79L (LIDOFILCON A&B)

FDA Premarket Approval P850058 S001

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

DeviceCUSTOMEYES 70L & 79L (LIDOFILCON A&B)
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCIBA VISION CORPORATION
Date Received1986-12-04
Decision Date1987-01-29
PMAP850058
SupplementS001
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
P850058Original Filing
S002 1989-07-24 Normal 180 Day Track
S001 1986-12-04 Normal 180 Day Track

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