SILSOFT (ELASTOFILCON A) CONTACT LENSES

Lens, Contact (polymethylmethacrylate)

FDA Premarket Approval P850068 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

DeviceSILSOFT (ELASTOFILCON A) CONTACT LENSES
Classification NameLens, Contact (polymethylmethacrylate)
Generic NameLens, Contact (polymethylmethacrylate)
ApplicantBausch & Lomb, Inc.
Date Received1990-11-05
Decision Date1991-11-15
PMAP850068
SupplementS006
Product CodeHPX
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 14853 Deveau Place minnetonka, MN 55345

Supplemental Filings

Supplement NumberDateSupplement Type
P850068Original Filing
S014 2022-02-01 Normal 180 Day Track
S013 2019-07-15 Real-time Process
S012 2014-09-19 30-day Notice
S011 2014-04-15 30-day Notice
S010 2014-04-15 30-day Notice
S009 2011-09-14 30-day Notice
S008 2001-01-09 Normal 180 Day Track
S007 1991-06-18 Normal 180 Day Track
S006 1990-11-05 Normal 180 Day Track
S005 1990-11-05 Normal 180 Day Track
S004 1989-10-18 Normal 180 Day Track
S003 1988-07-22 Special (immediate Track)
S002 1987-06-19 Normal 180 Day Track
S001 1987-02-02 30-Day Supplement

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