MIRASOL(TM)

FDA Premarket Approval P810008 S004

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

DeviceMIRASOL(TM)
Generic NameAccessories, Soft Lens Products
ApplicantWESLEY JESSEN CORP.
Date Received1983-06-17
Decision Date1983-08-26
PMAP810008
SupplementS004
Product CodeLPN 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 400 West Superior St. chicago, IL 60610

Supplemental Filings

Supplement NumberDateSupplement Type
P810008Original Filing
S006 1986-02-03
S005
S004 1983-06-17
S003 1982-10-19
S002 1982-09-29
S001 1982-04-23

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