INTACS PRESCRIPTION INSERTS

Implant, Corneal, Refractive

FDA Premarket Approval P980031 S009

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

Transfer of non-critical "as/manufactured" dimensional inspections of width, symmetry, outer diameter, arc length, and drill hole placement for machined intacs prescription inserts from biotest laboratories to ocular technology inc.

DeviceINTACS PRESCRIPTION INSERTS
Classification NameImplant, Corneal, Refractive
Generic NameImplant, Corneal, Refractive
ApplicantADDITION TECHNOLOGY
Date Received2005-10-31
Decision Date2005-11-23
PMAP980031
SupplementS009
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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