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FILL/FLUSH EXTRACTION SYSTEM FOR ACRYSOF, AND ACRYSOF RESTOR INTRAOCULAR LENSES

FDA premarket approval P040020/S033 · decided 2011-07-21

Approval details

PMA number
P040020
Supplement
S033
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
FILL/FLUSH EXTRACTION SYSTEM FOR ACRYSOF, AND ACRYSOF RESTOR INTRAOCULAR LENSES
Generic name
Lens, multifocal intraocular
Applicant
Alcon Research, Ltd.
Date received
2011-07-01
Decision date
2011-07-21
Days to decision
20 days
Decision code
OK30
Product code
MFK
Advisory committee
Ophthalmic
Expedited review
No
Location
Fort Worth, TX
Statement
CHANGE IN THE FILL/ FLUSH EXTRACTION SYSTEM FOR THE ACRYSOF AND ACRYSOF RESTOR INTRAOCULAR LENSES.

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