CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE

FDA Premarket Approval P990023 S008

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

Alternate process to automate the review and documentation of laboratory and process test results as part of the electronic batch record (ebr) system.

DeviceCELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE
Generic NameAid, Surgical, Viscoelastic
ApplicantALCON LABORATORIES
Date Received2009-09-15
Decision Date2009-10-15
PMAP990023
SupplementS008
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ALCON LABORATORIES 6201 South Freeway fort Worth, TX 76134

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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