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CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC

FDA premarket approval P820072/S017 · decided 1987-12-07

Approval details

PMA number
P820072
Supplement
S017
Supplement type
THIRTY DAY TRACK
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC
Generic name
intraocular lens
Applicant
Bausch & Lomb, Inc.
Date received
1987-06-08
Decision date
1987-12-07
Days to decision
182 days
Decision code
APPR
Product code
HQL
Advisory committee
Ophthalmic
Expedited review
No
Location
Rochester, NY

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RecordFirmDate
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Bausch + Lomb Injector System (K151102)Bausch & Lomb, Inc.2015-05-22
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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