OPUS - III CONTACT LENSES

FDA Premarket Approval P820074 S006

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

DeviceOPUS - III CONTACT LENSES
Generic NameLens, Contact (other Material) - Daily
ApplicantWESLEY JESSEN CORP.
Date Received1987-01-23
Decision Date1988-06-29
PMAP820074
SupplementS006
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 333 E. Howard Ave. des Plaines, IL 60018-5903

Supplemental Filings

Supplement NumberDateSupplement Type
P820074Original Filing
S006 1987-01-23 Normal 180 Day Track
S005
S004 1984-07-27
S003 1984-05-01
S002 1984-03-01
S001 1983-09-09

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