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.

• Device: PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES
• Generic Name: Intraocular Lens
• Applicant: ALCON LABORATORIES
• Date Received: 2009-06-30
• Decision Date: 2009-07-23
• PMA: P880087
• Supplement: S013
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134

Supplemental Filings

Supplement Number	Date	Supplement Type
P880087		Original 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 ID	PMA	Supp
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00380652535632	P880087	002
00380652535625	P880087	002
00380652535618	P880087	002
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