SATURN II(TM) (SYNERGICON A) CONTACT LENS

FDA Premarket Approval P840004 S007

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

DeviceSATURN II(TM) (SYNERGICON A) CONTACT LENS
Generic NameLens, Contact (polymethylmethacrylate)
ApplicantWESLEY JESSEN CORP.
Date Received1992-11-06
Decision Date1993-10-14
PMAP840004
SupplementS007
Product CodeHPX 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 333 E. Howard Ave. des Plaines, IL 60018-5903

Supplemental Filings

Supplement NumberDateSupplement Type
P840004Original Filing
S007 1992-11-06 Normal 180 Day Track
S006 1992-08-24 Normal 180 Day Track
S005 1989-04-17 Normal 180 Day Track
S004
S003 1986-11-25 30-Day Supplement
S002 1986-04-17
S001 1985-03-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.