INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)

Implant, Corneal, Refractive

FDA Premarket Approval P980031 S002

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

The 30-day notice requested the implementation of a qualified sampling plan for dimensional inspection of the product attributes: width, arc length, outside diameter, symmetry and hole placement.

• Device: INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
• Classification Name: Implant, Corneal, Refractive
• Generic Name: Implant, Corneal, Refractive
• Applicant: ADDITION TECHNOLOGY
• Date Received: 1999-12-23
• Decision Date: 2000-01-12
• PMA: P980031
• Supplement: S002
• 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