Clareon Intraocular Lenses with the AutonoMe Delivery System

FDA Premarket Approval P190018 S011

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

To add an alternate supplier for a raw material (i. E. Initiator) used in the manufacturing process

DeviceClareon Intraocular Lenses with the AutonoMe Delivery System
Generic NameIntraocular Lens
ApplicantAlcon Research, Ltd.
Date Received2021-03-26
Decision Date2021-04-22
PMAP190018
SupplementS011
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Alcon Research, Ltd. 6201 South Freeway, Tc-467 forth Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P190018Original Filing
S011 2021-03-26 30-day Notice
S010 2021-02-22 Normal 180 Day Track No User Fee
S009 2020-12-14 Real-time Process
S008 2020-10-30 30-day Notice
S007 2020-10-16 30-day Notice
S006 2020-08-31 30-day Notice
S005
S004 2020-05-19 30-day Notice
S003
S002
S001

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