Atlas FDA

PERMATINT(R)

FDA premarket approval P820059/S015 · decided 1990-01-23

Approval details

PMA number
P820059
Supplement
S015
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
PERMATINT(R)
Generic name
Lenses, soft contact, daily wear
Applicant
Wesley Jessen Corp.
Date received
1989-07-24
Decision date
1990-01-23
Days to decision
183 days
Decision code
APPR
Product code
LPL
Advisory committee
Ophthalmic
Expedited review
No
Location
Des Plaines, IL

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510(k) clearances by this applicant

RecordFirmDate
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS (K994335)Wesley Jessen Corp.2000-03-20
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C (K000439)Wesley Jessen Corp.2000-03-20
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI (K993935)Wesley Jessen Corp.1999-12-21
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES (K991000)Wesley Jessen Corp.1999-06-28
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS (K991550)Wesley Jessen Corp.1999-05-14
PRECISION UV (VASURFILCON A) (K982988)Wesley Jessen Corp.1999-01-06
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS (K982344)Wesley Jessen Corp.1998-12-22
D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES (K965052)Wesley Jessen Corp.1997-05-14