GP-II(TM) (POROFOCON B) CONTACT LENS

FDA Premarket Approval N18032 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

DeviceGP-II(TM) (POROFOCON B) CONTACT LENS
Generic NameLens, Contact (polymethylmethacrylate)
ApplicantWESLEY JESSEN CORP.
Date Received1982-01-21
Decision Date1982-03-25
PMAN18032
SupplementS004
Product CodeHPX 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 333 E. Howard Ave. des Plaines, IL 60018-5903

Supplemental Filings

Supplement NumberDateSupplement Type
N18032Original Filing
S006 1983-04-05
S005 1982-08-25
S004 1982-01-21
S003 1981-12-14
S002 1980-12-16
S001 1979-11-05

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