FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES

FDA Premarket Approval P000030 S002

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

Manufacturing changes to include the installation and qualification of new (i. E. , replacement) systems for the production of phosphate buffered saline and for the production of phosphate buffered saline with hydrogen peroxide at the batam, indonesia production facility.

DeviceFOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
Generic NameLenses, Soft Contact, Extended Wear
ApplicantAlcon Laboratories, Inc.
Date Received2016-02-26
Decision Date2016-03-23
PMAP000030
SupplementS002
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099

Supplemental Filings

Supplement NumberDateSupplement Type
P000030Original Filing
S003 2016-06-01 30-day Notice
S002 2016-02-26 30-day Notice
S001 2016-02-16 30-day Notice

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