3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Intraocular Lens

FDA Premarket Approval P830040 S026

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 sterilization process using 100% ethylene oxide, an alterante microbiological monitoring system and one resterilization in the event of an "aborted cycle. "

Device3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantALCONRESEARCH,LTD.
Date Received1996-08-08
Decision Date1998-09-04
PMAP830040
SupplementS026
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ALCONRESEARCH,LTD. 6201 South Freeway fort Worth,, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P830040Original Filing
S026 1996-08-08 Normal 180 Day Track
S025 1995-08-09 Normal 180 Day Track
S024 1995-01-31 Normal 180 Day Track
S023 1991-10-01 Normal 180 Day Track
S022 1991-08-22 Normal 180 Day Track
S021 1991-07-01 Normal 180 Day Track
S020 1991-05-08 Normal 180 Day Track
S019
S018 1991-03-12 Normal 180 Day Track
S017 1991-02-14 Normal 180 Day Track
S016
S015 1990-07-05 Normal 180 Day Track
S014 1990-04-24 Normal 180 Day Track
S013 1989-12-29 Normal 180 Day Track
S012
S011 1988-12-23 Normal 180 Day Track
S010 1988-12-19 Normal 180 Day Track
S009 1988-12-14 Normal 180 Day Track
S008 1988-11-14 Panel Track
S007
S006
S005
S004
S003
S002 1985-04-10
S001 1984-11-09

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