PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES

FDA Premarket Approval P880087 S013

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

Use of an alternate ethylene oxide gas blend sterilant used during terminal sterilization.

DevicePMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES
Generic NameIntraocular Lens
ApplicantALCON LABORATORIES
Date Received2009-06-30
Decision Date2009-07-23
PMAP880087
SupplementS013
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P880087Original Filing
S031 2021-06-21 Normal 180 Day Track No User Fee
S030 2020-11-25 30-day Notice
S029 2019-07-05 30-day Notice
S028 2019-03-25 30-day Notice
S027 2019-03-25 30-day Notice
S026 2016-11-30 30-day Notice
S025 2016-08-03 30-day Notice
S024
S023 2015-12-09 30-day Notice
S022 2013-04-22 30-day Notice
S021 2012-12-26 Normal 180 Day Track No User Fee
S020 2012-10-01 30-day Notice
S019 2011-06-24 30-day Notice
S018 2010-08-25 30-day Notice
S017 2010-08-10 30-day Notice
S016 2010-05-03 30-day Notice
S015 2010-05-03 30-day Notice
S014 2009-12-24 30-day Notice
S013 2009-06-30 30-day Notice
S012 2006-07-24 30-day Notice
S011 2004-10-18 135 Review Track For 30-day Notice
S010 2004-04-16 Real-time Process
S009 1996-10-24 Normal 180 Day Track
S008
S007 1996-08-08 Normal 180 Day Track
S006 1995-08-09 Normal 180 Day Track
S005 1995-01-31 Normal 180 Day Track
S004 1991-08-21 Normal 180 Day Track
S003
S002 1990-03-26 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
00380652535823 P880087 002
00380652535632 P880087 002
00380652535625 P880087 002
00380652535618 P880087 002
00380652535601 P880087 002
00380652535595 P880087 002
00380650701473 P880087 002
00380650701466 P880087 002
00380650701442 P880087 002
00380650701435 P880087 002
00380650701428 P880087 002
00380650701411 P880087 002
00380650701404 P880087 002
00380650701398 P880087 002
00380650701381 P880087 002
00380650701374 P880087 002
00380650701367 P880087 002
00380652535649 P880087 002
00380652535656 P880087 002
00380652535816 P880087 002
00380652535809 P880087 002
00380652535793 P880087 002
00380652535786 P880087 002
00380652535779 P880087 002
00380652535762 P880087 002
00380652535755 P880087 002
00380652535748 P880087 002
00380652535731 P880087 002
00380652535724 P880087 002
00380652535717 P880087 002
00380652535700 P880087 002
00380652535694 P880087 002
00380652535687 P880087 002
00380652535670 P880087 002
00380652535663 P880087 002
00380650701350 P880087 002
00380650701343 P880087 002
00380650701336 P880087 002
00380650701145 P880087 002
00380650701138 P880087 002
00380650701121 P880087 002
00380650701114 P880087 002
00380650701107 P880087 002
00380650701091 P880087 002
00380650701084 P880087 002
00380650701077 P880087 002
00380650701060 P880087 002
00380650701053 P880087 002
00380650701046 P880087 002
00380650141224 P880087 002
00380650141217 P880087 002
00380650141200 P880087 002
00380650141194 P880087 002
00380650141187 P880087 002
00380650701152 P880087 002
00380650701169 P880087 002
00380650701329 P880087 002
00380650701312 P880087 002
00380650701305 P880087 002
00380650701299 P880087 002
00380650701282 P880087 002
00380650701275 P880087 002
00380650701268 P880087 002
00380650701251 P880087 002
00380650701244 P880087 002
00380650701237 P880087 002
00380650701220 P880087 002
00380650701213 P880087 002
00380650701206 P880087 002
00380650701190 P880087 002
00380650701183 P880087 002
00380650701176 P880087 002
00380650141170 P880087 002
00380652535830 P880087 002
00380652536561 P880087 002
00380652536370 P880087 002
00380652536363 P880087 002
00380652536356 P880087 002
00380652536349 P880087 002
00380652536332 P880087 002
00380652536325 P880087 002
00380652536318 P880087 002
00380652536301 P880087 002
00380652536295 P880087 002
00380652536288 P880087 002
00380652536271 P880087 002
00380652536264 P880087 002
00380652536257 P880087 002
00380652536240 P880087 002
00380652536233 P880087 002
00380652536226 P880087 002
00380652536387 P880087 002
00380652536394 P880087 002
00380652536554 P880087 002
00380652536547 P880087 002
00380652536530 P880087 002
00380652536523 P880087 002
00380652536516 P880087 002
00380652536509 P880087 002
00380652536493 P880087 002
00380652536486 P880087 002
00380652536479 P880087 002
00380652536462 P880087 002
00380652536455 P880087 002
00380652536448 P880087 002
00380652536431 P880087 002
00380652536424 P880087 002
00380652536417 P880087 002
00380652536400 P880087 002
00380652536219 P880087 002
00380652536202 P880087 002
00380652536196 P880087 002
00380652536004 P880087 002
00380652535991 P880087 002
00380652535984 P880087 002
00380652535977 P880087 002
00380652535960 P880087 002
00380652535953 P880087 002
00380652535946 P880087 002
00380652535939 P880087 002
00380652535922 P880087 002
00380652535915 P880087 002
00380652535908 P880087 002
00380652535892 P880087 002
00380652535885 P880087 002
00380652535878 P880087 002
00380652535861 P880087 002
00380652535854 P880087 002
00380652536011 P880087 002
00380652536028 P880087 002
00380652536189 P880087 002
00380652536172 P880087 002
00380652536165 P880087 002
00380652536158 P880087 002
00380652536141 P880087 002
00380652536134 P880087 002
00380652536127 P880087 002
00380652536110 P880087 002
00380652536103 P880087 002
00380652536097 P880087 002
00380652536080 P880087 002
00380652536073 P880087 002
00380652536066 P880087 002
00380652536059 P880087 002
00380652536042 P880087 002
00380652536035 P880087 002
00380652535847 P880087 002

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.