ANTERIOR CHAMBER INTRAOCULAR LENS

FDA Premarket Approval P880087 S006

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

Approval for an alternate steriliztion process including aeratio time and the establishment of the biological indicator incubation time

• Device: ANTERIOR CHAMBER INTRAOCULAR LENS
• Generic Name: Intraocular Lens
• Applicant: ALCON LABORATORIES
• Date Received: 1995-08-09
• Decision Date: 1995-12-13
• PMA: P880087
• Supplement: S006
• Product Code: HQL
• Docket Number: N
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• 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
00380652535823	P880087	002
00380652535632	P880087	002
00380652535625	P880087	002
00380652535618	P880087	002
00380652535601	P880087	002
00380652535595	P880087	002
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00380650701428	P880087	002
00380650701411	P880087	002
00380650701404	P880087	002
00380650701398	P880087	002
00380650701381	P880087	002
00380650701374	P880087	002
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00380652535649	P880087	002
00380652535656	P880087	002
00380652535816	P880087	002
00380652535809	P880087	002
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00380652535779	P880087	002
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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
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00380650701077	P880087	002
00380650701060	P880087	002
00380650701053	P880087	002
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00380650141224	P880087	002
00380650141217	P880087	002
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00380650141194	P880087	002
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00380650701213	P880087	002
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00380652536233	P880087	002
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00380652536387	P880087	002
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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
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00380652536189	P880087	002
00380652536172	P880087	002
00380652536165	P880087	002
00380652536158	P880087	002
00380652536141	P880087	002
00380652536134	P880087	002
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00380652536103	P880087	002
00380652536097	P880087	002
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00380652536073	P880087	002
00380652536066	P880087	002
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00380652536042	P880087	002
00380652536035	P880087	002
00380652535847	P880087	002