Ultra (samfilcon A) Contact Lens

FDA Premarket Approval P170035 S013

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

Approval to remove the sagittal depth measurement acceptance criteria from the finished product specifications for ultra (samfilcon a) contact lens.

DeviceUltra (samfilcon A) Contact Lens
Generic NameLenses, Soft Contact, Extended Wear
ApplicantBausch And Lomb, Inc.
Date Received2021-06-03
Decision Date2021-08-27
PMAP170035
SupplementS013
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Bausch And Lomb, Inc. 1400 North Goodman Street rochester, NY 14609

Supplemental Filings

Supplement NumberDateSupplement Type
P170035Original Filing
S013 2021-06-03 Real-time Process
S012 2021-03-12 30-day Notice
S011 2020-10-30 30-day Notice
S010 2020-09-29 30-day Notice
S009 2020-09-02 30-day Notice
S008 2020-06-18 30-day Notice
S007 2019-11-20 30-day Notice
S006 2019-08-14 30-day Notice
S005
S004 2019-06-14 30-day Notice
S003 2019-02-04 Normal 180 Day Track
S002
S001

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