Biomedics 55 Asphere

FDA Premarket Approval P890023 S048

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

DeviceBiomedics 55 Asphere
Generic NameLenses, Soft Contact, Extended Wear
ApplicantTHE COOPER COMPANIES6150 Stoneridge Mall Roadsuite 370pleasanton, CA 94588 PMA NumberP890023 Supplement NumberS048 Date Received04/26/2022 Decision Date05/24/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-26
Decision Date2022-05-24
PMAP890023
SupplementS048
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressTHE COOPER COMPANIES
6150 Stoneridge Mall Road
suite 370
pleasanton, CA 94588 PMA NumberP890023 Supplement NumberS048 Date Received04/26/2022 Decision Date05/24/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Addition Of Biomedics 55 Asphere Lens Capability To The Low Volume Automation (LVA1) Manufacturing Line At The CooperVision, Inc. Facility In Scottsville, New York

Supplemental Filings

Supplement NumberDateSupplement Type
P890023Original Filing
S048 2022-04-26 30-day Notice
S047 2020-09-25 30-day Notice
S046
S045 2020-08-24 30-day Notice
S044 2020-08-20 30-day Notice
S043 2020-08-03 30-day Notice
S042 2020-01-15 30-day Notice
S041
S040 2019-12-03 30-day Notice
S039 2019-10-15 30-day Notice
S038 2019-08-13 30-day Notice
S037 2019-02-26 30-day Notice
S036 2019-02-08 30-day Notice
S035 2018-08-09 Normal 180 Day Track No User Fee
S034 2018-06-18 Real-time Process
S033 2018-06-15 Real-time Process
S032 2018-04-05 Normal 180 Day Track No User Fee
S031 2018-03-16 135 Review Track For 30-day Notice
S030 2018-01-16 135 Review Track For 30-day Notice
S029 2017-10-24 30-day Notice
S028 2017-08-04 Real-time Process
S027 2017-01-30 30-day Notice
S026 2017-01-08 30-day Notice
S025 2016-04-13 Normal 180 Day Track No User Fee
S024 2015-12-22 30-day Notice
S023 2015-07-02 30-day Notice
S022 2014-09-08 Normal 180 Day Track No User Fee
S021 2013-11-13 135 Review Track For 30-day Notice
S020 2013-11-12 30-day Notice
S019 2013-07-22 30-day Notice
S018 2011-11-01 30-day Notice
S017 2010-04-26 135 Review Track For 30-day Notice
S016 2004-08-18 Real-time Process
S015 2004-07-02 Normal 180 Day Track No User Fee
S014 2003-12-22 Normal 180 Day Track No User Fee
S013 2002-01-18 Normal 180 Day Track
S012
S011 2001-07-20 Normal 180 Day Track
S010
S009 1999-09-17 Normal 180 Day Track
S008 1999-07-29 30-day Notice
S007 1999-04-20 Real-time Process
S006 1996-02-13 Normal 180 Day Track
S005 1995-10-23 Normal 180 Day Track
S004 1995-10-02 Normal 180 Day Track
S003 1995-09-29 Normal 180 Day Track
S002 1993-05-24 Normal 180 Day Track
S001 1990-10-31 Normal 180 Day Track

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