MIRASOL(TM)

FDA Premarket Approval P810008 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

DeviceMIRASOL(TM)
Generic NameAccessories, Soft Lens Products
ApplicantWESLEY JESSEN CORP.
Date Received1982-09-29
Decision Date1982-11-22
PMAP810008
SupplementS002
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

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