OPTIGUIDE(TM) CYLINDRICAL FIBER OPTIC

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Premarket Approval P940010 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

Approval for commerical distributing of the modified dcyl cylindrical fiber optics which incorporate a glued diffusing tip in place of the previously approved threaded tip. The device, as modified, will be marketed under the trade name optiguide cylindrical fiber optic (dcyl2 diffuser series and is indicated for: palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinon of their physician, cannot be satisfactorily treated with nd:yag laser therapy, and treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.

• Device: OPTIGUIDE(TM) CYLINDRICAL FIBER OPTIC
• Classification Name: System, Laser, Fiber Optic, Photodynamic Therapy
• Generic Name: System, Laser, Fiber Optic, Photodynamic Therapy
• Applicant: CONCORDIA LABORATORIES, INC
• Date Received: 1998-08-21
• Decision Date: 1998-11-23
• PMA: P940010
• Supplement: S005
• Product Code: MVG
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: CONCORDIA LABORATORIES, INC 5 Canewood Industrial Park st Michael BB110

Supplemental Filings

Supplement Number	Date	Supplement Type
P940010		Original Filing
S017	2020-11-02	Real-time Process
S016	2018-12-19	Normal 180 Day Track
S015	2018-04-03	Real-time Process
S014	2018-01-16	30-day Notice
S013	2017-12-18	30-day Notice
S012	2017-10-24	Real-time Process
S011	2013-09-13	Real-time Process
S010	2002-06-12	Panel Track
S009	2000-04-17	Normal 180 Day Track
S008	1999-09-21	Normal 180 Day Track
S007	1999-07-08	Normal 180 Day Track
S006	1999-02-08	Normal 180 Day Track
S005	1998-08-21	Normal 180 Day Track
S004	1998-03-24	Normal 180 Day Track
S003	1997-02-18	Normal 180 Day Track
S002	1997-02-10	Normal 180 Day Track
S001	1996-07-03	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00376128000087	P940010	000
00376128000148	P940010	000
00376128000131	P940010	000
00376128000124	P940010	000
00376128000117	P940010	000
00376128000100	P940010	000
00376128000094	P940010	000
00376128000278	P940010	001
00376128000261	P940010	001
00376128000254	P940010	001
00376128000247	P940010	001
00376128000230	P940010	001
00376128000223	P940010	001
00376128000148	P940010	001
00376128000087	P940010	001
00376128000131	P940010	001
00376128000124	P940010	001
00376128000117	P940010	001
00376128000100	P940010	001
00376128000094	P940010	001
00376128000070	P940010	011
00376128000063	P940010	011
00376128000049	P940010	011
00376128000032	P940010	011
00376128000025	P940010	011
00376128000018	P940010	011
00376128000056	P940010	011
00376128000346	P940010	016
00376128000353	P940010	016
00376128000360	P940010	016
00376128000377	P940010	016
00376128000391	P940010	016
00376128000384	P940010	016