INTACS PRESCRIPTION INSERTS

Implant, Corneal, Refractive

FDA Premarket Approval P980031 S005

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

Implementing the outsourcing of the inspection, cleaning and packaging operations for intacs inserts to the qualified contract manufacturer, biotest laboratories, inc.

• Device: INTACS PRESCRIPTION INSERTS
• Classification Name: Implant, Corneal, Refractive
• Generic Name: Implant, Corneal, Refractive
• Applicant: ADDITION TECHNOLOGY
• Date Received: 2003-05-02
• Decision Date: 2003-05-30
• PMA: P980031
• Supplement: S005
• Product Code: LQE
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: ADDITION TECHNOLOGY 820 Oak Creek Drive lombard, IL 60148

Supplemental Filings

Supplement Number	Date	Supplement Type
P980031		Original 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 ID	PMA	Supp
00866304000104	P980031	000
00850048576216	P980031	000
00850048576209	P980031	000
00850048576193	P980031	000