INTACS CORNEAL IMPLANTS

Implant, Corneal, Refractive

FDA Premarket Approval P980031 S011

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

Outsourcing of the intacs segment thickness and packaging component inspection activities.

DeviceINTACS CORNEAL IMPLANTS
Classification NameImplant, Corneal, Refractive
Generic NameImplant, Corneal, Refractive
ApplicantADDITION TECHNOLOGY
Date Received2012-11-14
Decision Date2012-12-19
PMAP980031
SupplementS011
Product CodeLQE
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ADDITION TECHNOLOGY 820 Oak Creek Drive lombard, IL 60148

Supplemental Filings

Supplement NumberDateSupplement Type
P980031Original Filing
S012 2012-12-12 135 Review Track For 30-day Notice
S011 2012-11-14 30-day Notice
S010
S009 2005-10-31 30-day Notice
S008 2004-06-10 Normal 180 Day Track No User Fee
S007 2004-05-19 Normal 180 Day Track No User Fee
S006 2003-05-14 Normal 180 Day Track No User Fee
S005 2003-05-02 30-day Notice
S004 2000-02-23 Normal 180 Day Track
S003 2000-02-22 30-day Notice
S002 1999-12-23 30-day Notice
S001 1999-11-03 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00866304000104 P980031 000
00850048576216 P980031 000
00850048576209 P980031 000
00850048576193 P980031 000

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