CELLUGEL OVD

FDA Premarket Approval P990023 S017

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

DeviceCELLUGEL OVD
Generic NameAid, Surgical, Viscoelastic
ApplicantALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS017 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-23
Decision Date2022-09-15
PMAP990023
SupplementS017
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressALCON LABORATORIES
6201 South Freeway
fort Worth, TX 76134 PMA NumberP990023 Supplement NumberS017 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Change To The Pouch Seal Integrity Test Method For The Testing Of The CELLUGEL OVD Pouch

Supplemental Filings

Supplement NumberDateSupplement Type
P990023Original Filing
S018 2022-08-24 30-day Notice
S017 2022-08-23 30-day Notice
S016 2016-06-17 Normal 180 Day Track
S015 2016-04-28 Real-time Process
S014 2016-04-25 30-day Notice
S013 2015-04-23 Normal 180 Day Track
S012 2014-01-31 30-day Notice
S011 2011-04-19 30-day Notice
S010 2010-10-15 30-day Notice
S009 2010-05-24 30-day Notice
S008 2009-09-15 30-day Notice
S007 2009-08-04 30-day Notice
S006 2008-11-24 30-day Notice
S005 2008-10-31 30-day Notice
S004 2008-04-08 30-day Notice
S003 2004-05-14 Special (immediate Track)
S002 2003-10-24 Special (immediate Track)
S001 2000-04-24 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00380651838109 P990023 000

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