Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric

FDA Premarket Approval P190018 S006

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

Addition of an alternate supplier for the autonome delivery system nozzle component (v. 3. 6).

DeviceClareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric
Generic NameIntraocular Lens
ApplicantAlcon Research, Ltd.
Date Received2020-08-31
Decision Date2020-09-29
PMAP190018
SupplementS006
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
S006 2020-08-31 30-day Notice
S005
S004 2020-05-19 30-day Notice
S003
S002
S001

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