Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

FDA Premarket Approval P090022 S037

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

Qualifying the addition of a prewash step to the manufacturing process for vials used to package its intraocular lenses (iols)

DeviceSoftec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs
Generic NameIntraocular Lens
ApplicantLENSTEC, INC.
Date Received2020-09-23
Decision Date2020-10-23
PMAP090022
SupplementS037
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address LENSTEC, INC. 1765 Commerce Ave N st. Petersburg, FL 33716

Supplemental Filings

Supplement NumberDateSupplement Type
P090022Original Filing
S037 2020-09-23 30-day Notice
S036 2020-09-21 30-day Notice
S035 2018-08-07 30-day Notice
S034 2017-05-12 30-day Notice
S033
S032 2017-02-17 30-day Notice
S031 2017-01-12 30-day Notice
S030 2016-12-19 30-day Notice
S029 2016-08-29 30-day Notice
S028 2016-08-29 30-day Notice
S027 2016-01-20 30-day Notice
S026 2015-12-23 Real-time Process
S025 2015-09-30 135 Review Track For 30-day Notice
S024 2014-12-15 30-day Notice
S023 2014-06-16 30-day Notice
S022 2014-05-12 Real-time Process
S021 2014-03-19 30-day Notice
S020 2014-03-18 Normal 180 Day Track
S019 2013-08-27 30-day Notice
S018 2013-06-07 30-day Notice
S017 2013-05-22 Real-time Process
S016 2013-03-08 30-day Notice
S015 2013-01-29 30-day Notice
S014 2012-08-27 30-day Notice
S013 2012-07-24 Special (immediate Track)
S012 2012-04-20 Normal 180 Day Track
S011 2012-03-14 Real-time Process
S010 2011-11-02 Normal 180 Day Track No User Fee
S009 2011-08-31 135 Review Track For 30-day Notice
S008 2011-08-29 30-day Notice
S007 2011-08-18 135 Review Track For 30-day Notice
S006 2011-07-28 30-day Notice
S005 2011-07-26 Real-time Process
S004 2010-12-15 Real-time Process
S003
S002 2010-07-02 Real-time Process
S001 2010-05-13 Real-time Process

NIH GUDID Devices

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