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STORZ IOL DISTRIBUTE/OPTICAL RADIATION

FDA premarket approval P880090/S007 · decided 1993-08-11

Approval details

PMA number
P880090
Supplement
S007
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
STORZ IOL DISTRIBUTE/OPTICAL RADIATION
Generic name
intraocular lens
Applicant
Bausch & Lomb, Inc.
Date received
1991-10-08
Decision date
1993-08-11
Days to decision
673 days
Decision code
APPR
Product code
HQL
Advisory committee
Ophthalmic
Expedited review
No
Location
Irvine, CA

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RecordFirmDate
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Crystalsert Lens Delivery System (K173480)Bausch & Lomb, Inc.2017-12-11
Bausch + Lomb Injector System (K151102)Bausch & Lomb, Inc.2015-05-22
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, (K131208)Bausch & Lomb, Inc.2013-09-11
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI (K122575)Bausch & Lomb, Inc.2012-12-20
BAUSCH & LOMB IOL INJECTOR (K113852)Bausch & Lomb, Inc.2012-09-28
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909)Bausch & Lomb, Inc.2012-04-30
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877)Bausch & Lomb, Inc.2012-01-24